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Product Approvals and Launches

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class="pb-2">The <em>AJMC</em><sup class="text-inherit">® </sup>Product Approvals and Launches page will cover the latest FDA product approvals, as well as product launches in the United States.</p></div></div><div class="px-6 sm:px-0 flex flex-wrap w-full"><div class="jsx-ad50481d5ee26850 w-full h-full"><div><div><div class="text-[8px] text-center text-gray-500 hidden">Advertisement</div><div id="div-gpt-ad-infeed-1"></div></div></div><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/risdiplam-tablet-for-spinal-muscular-atropy-receives-fda-approval"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/2f366a4ab7421a6a697b539c22b8aedf46713899-6000x4000.jpg?fit=crop&amp;auto=format" alt="FDA approval. | Image Credit: syahrir - stock.adobe.com" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">February 12th 2025</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/risdiplam-tablet-for-spinal-muscular-atropy-receives-fda-approval">Risdiplam Tablet for Spinal Muscular Atrophy Receives FDA Approval</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/giuliana-grossi">Giuliana Grossi</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/risdiplam-tablet-for-spinal-muscular-atropy-receives-fda-approval"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">The 5 mg risdiplam tablet provides the same efficacy and safety for spinal muscular atrophy as the currently available oral solution.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-mirdametinib-for-neurofibromatosis-type-1-with-plexiform-neurofibromas"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/b0002ea79080e3493345e3c993b00be4690f0087-4279x2706.jpg?fit=crop&amp;auto=format" alt="FDA approved. | Image Credit: Pawel - stock.adobe.com" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">February 12th 2025</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-mirdametinib-for-neurofibromatosis-type-1-with-plexiform-neurofibromas">FDA Approves Mirdametinib for Neurofibromatosis Type 1 With Plexiform Neurofibromas</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/giuliana-grossi">Giuliana Grossi</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-mirdametinib-for-neurofibromatosis-type-1-with-plexiform-neurofibromas"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">Adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas that are not amenable to complete surgical resection are indicated in the approval.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex md:hidden justify-center items-center"></div><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-brentuximab-vedotin-lenalidomide-rituximab-triplet-for-r-r-lbcl"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/ff9ffbca858fbb2833bf65b18c99e5a9c74b8707-1200x738.jpg?fit=crop&amp;auto=format" alt="FDA approval | Image Credit: © wladimir1804 - stock.adobe.com" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">Published: <!-- -->February 12th 2025<!-- --> <!-- -->|<!-- --> <!-- -->Updated:<!-- --> <!-- -->February 12th 2025</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-brentuximab-vedotin-lenalidomide-rituximab-triplet-for-r-r-lbcl">FDA Approves Brentuximab Vedotin, Lenalidomide, Rituximab Triplet for R/R LBCL</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/maggie-l-shaw">Maggie L. Shaw</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-brentuximab-vedotin-lenalidomide-rituximab-triplet-for-r-r-lbcl"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">Interim data from the ECHELON-3 trial previously showed that adding brentuximab vedotin to lenalidomide and rituximab improved overall survival among patients who have relapsed or refractory large B-cell lymphoma (R/R LBCL).</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/bimzelx-expands-treatment-options-for-inflammatory-conditions"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/6423a9f30c8bc429e9005755f0b06b2c4bd99078-1893x986.png?fit=crop&amp;auto=format" alt="Jeff Stark, MD, vice president, head of medical immunology, UCB." width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">February 10th 2025</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/bimzelx-expands-treatment-options-for-inflammatory-conditions">Bimekizumab-bkzx Expands Treatment Options for Inflammatory Conditions</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/cameron-santoro">Cameron Santoro</a><span class="jsx-ad50481d5ee26850 mr-1 ml-[1px]"> </span><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/maggie-l-shaw">Maggie L. Shaw</a><span class="jsx-ad50481d5ee26850 mr-1 ml-[1px]"> </span><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/jeffrey-stark-md">Jeffrey Stark, MD</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/bimzelx-expands-treatment-options-for-inflammatory-conditions"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">Jeffrey Stark, MD, vice president and head of medical immunology at UCB, discusses tailored dosing of bimekizumab-bkzx (Bimzelx) for various inflammatory conditions, highlighting its 5 FDA approvals and the remaining challenges.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/evolent-s-wonsettler-sees-outcomes-based-reimbursement-as-a-healthy-tool-"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/8aa43400435897ab5bb0a33acb12825a618857bf-323x323.jpg?fit=crop&amp;auto=format" alt="Terra Wonsettler, PharmD, MBA | Image credit: Evolent" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">February 7th 2025</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/evolent-s-wonsettler-sees-outcomes-based-reimbursement-as-a-healthy-tool-">Evolent’s Wonsettler Sees Outcomes-Based Reimbursement as “A Healthy Tool”</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/interview-by-mary-caffrey">Interview by Mary Caffrey</a><span class="jsx-ad50481d5ee26850 mr-1 ml-[1px]"> </span><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/terra-wonsettler-pharmd-mba">Terra Wonsettler, PharmD, MBA</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/evolent-s-wonsettler-sees-outcomes-based-reimbursement-as-a-healthy-tool-"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">Terra Wonsettler, PharmD, MBA, vice president of pharmacy for Evolent, discusses the recent HHS OIG report that stemmed from the 2021 FDA approval of aducanumab (Aduhelm) and use of the accelerated approval pathway.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/treosulfan-approval-offers-novel-option-for-allo-hsct-conditioning-in-aml-mds"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/b60f4e85aeb9d33a7da0658f96541e8b5373838c-1032x574.png?fit=crop&amp;auto=format" alt="Mikkael Sekeres, MD" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">February 7th 2025</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/treosulfan-approval-offers-novel-option-for-allo-hsct-conditioning-in-aml-mds">Treosulfan Approval Offers Novel Option for Allo-HSCT Conditioning in AML/MDS</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/rose-mcnulty">Rose McNulty</a><span class="jsx-ad50481d5ee26850 mr-1 ml-[1px]"> </span><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/mikkael-a-sekeres-md">Mikkael A. Sekeres, MD</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/treosulfan-approval-offers-novel-option-for-allo-hsct-conditioning-in-aml-mds"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">Mikkael A. Sekeres, MD, Sylvester Comprehensive Cancer Center, discusses the potential benefits of treosulfan, a newly approved agent for allogeneic hematopoietic stem cell transplantation (allo-HSCT) conditioning in acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). </div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div><div><div class="text-[8px] text-center text-gray-500 hidden">Advertisement</div><div id="div-gpt-ad-infeed-7"></div></div></div><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/treosulfan-shown-effective-safe-as-conditioning-for-allo-hsct-in-aml-mds"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/10bc2cb3804d6a94f413d9a5cb8071be332f7ad5-724x404.png?fit=crop&amp;auto=format" alt="Mikkael Sekeres, MD" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">February 6th 2025</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/treosulfan-shown-effective-safe-as-conditioning-for-allo-hsct-in-aml-mds">Treosulfan Shown Effective, Safe as Conditioning for Allo-HSCT in AML/MDS</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/mikkael-a-sekeres-md">Mikkael A. Sekeres, MD</a><span class="jsx-ad50481d5ee26850 mr-1 ml-[1px]"> </span><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/rose-mcnulty">Rose McNulty</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/treosulfan-shown-effective-safe-as-conditioning-for-allo-hsct-in-aml-mds"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">Mikkael A. Sekeres, MD, of Sylvester Comprehensive Cancer Center, University of Miami, discussed data supporting the FDA approval of treosulfan as part of conditioning for allogeneic hematopoeitic stem cell transplantation (allo-HSCT). </div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/dr-jeff-stark-new-bimzelx-dose-offers-simplicity-and-choice"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/893e836b204582bb2c27b9679b0ceab9e719963e-1200x675.jpg?fit=crop&amp;auto=format" alt="Jeff Stark, MD, UCB" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">February 6th 2025</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/dr-jeff-stark-new-bimzelx-dose-offers-simplicity-and-choice">Dr Jeff Stark: New Bimzelx Dose Offers Simplicity and Choice</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/maggie-l-shaw">Maggie L. Shaw</a><span class="jsx-ad50481d5ee26850 mr-1 ml-[1px]"> </span><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/jeff-stark-md">Jeff Stark, MD</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/dr-jeff-stark-new-bimzelx-dose-offers-simplicity-and-choice"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">On October 14, 2024, the FDA approved a 320-mg single dose of bimekizumab-bkzx (Bimzelx; UCB) in a 2-mL prefilled syringe and autoinjector; both forms are now commercially available in the US.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex md:hidden justify-center items-center"></div><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-first-subcutaneous-apomorphine-device-for-parkinson-disease"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/8f653113486fc52cd1daac9f7124732eb4da7809-1200x800.jpg?fit=crop&amp;auto=format" alt="Parkinson disease | Image credit: wladimir1804 - stock.adobe.com" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">February 4th 2025</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-first-subcutaneous-apomorphine-device-for-parkinson-disease">FDA Approves First Subcutaneous Apomorphine Device for Parkinson Disease</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/skylar-jeremias">Skylar Jeremias</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-first-subcutaneous-apomorphine-device-for-parkinson-disease"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">The FDA has approved the first and only subcutaneous apomorphine infusion device, apomorphine hydrochloride injection (Onapgo), for the treatment of adults with advanced Parkinson disease.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-ranibizumab-injection-in-treatment-of-dme"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/b0002ea79080e3493345e3c993b00be4690f0087-4279x2706.jpg?fit=crop&amp;auto=format" alt="FDA approved. | Image Credit: Pawel - stock.adobe.com" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">Published: <!-- -->February 4th 2025<!-- --> <!-- -->|<!-- --> <!-- -->Updated:<!-- --> <!-- -->February 4th 2025</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-ranibizumab-injection-in-treatment-of-dme">FDA Approves Ranibizumab Implant in Treatment of DME</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/julia-bonavitacola">Julia Bonavitacola</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-ranibizumab-injection-in-treatment-of-dme"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">The ranibizumab injection delivered through an implant device could be administered in a convenient schedule twice per year for the treatment of diabetic macular edema (DME).</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-celltrion-s-tocilizumab-anoh-biosimilar-to-actemra"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/a0cb6495daeaee9e3fb7822d0e083c4ace68041e-6000x4000.jpg?fit=crop&amp;auto=format" alt="FDA approved. | Image Credit: Olivier Le Moal - stock.adobe.com " width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">January 31st 2025</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-celltrion-s-tocilizumab-anoh-biosimilar-to-actemra">FDA Approves Celltrion’s Tocilizumab-anoh, Biosimilar to Actemra</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/cameron-santoro">Cameron Santoro</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-celltrion-s-tocilizumab-anoh-biosimilar-to-actemra"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">Avtozma, the third biosimilar to Actemra, has received FDA approval for multiple inflammatory diseases and COVID-19, potentially expanding treatment access for patients. </div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/suzetrigine-the-first-non-opiate-pain-therapy-is-fda-approved"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/2f366a4ab7421a6a697b539c22b8aedf46713899-6000x4000.jpg?fit=crop&amp;auto=format" alt="Image Credit: Image Credit: syahrir - stock.adobe.com" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">January 31st 2025</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/suzetrigine-the-first-non-opiate-pain-therapy-is-fda-approved">Suzetrigine: First-in-Class Nonopioid Pain Therapy Is Approved by FDA</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/giuliana-grossi">Giuliana Grossi</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/suzetrigine-the-first-non-opiate-pain-therapy-is-fda-approved"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">Suzetrigine (Journavx) is the first new drug approved to treat acute pain in over 20 years and the first to be classified as a selective NaV1.8 pain signal inhibitor, an alternative to opiates.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div><div><div class="text-[8px] text-center text-gray-500 hidden">Advertisement</div><div id="div-gpt-ad-infeed-13"></div></div></div><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-companion-diagnostic-for-tovorafenib-in-braf-altered-pediatric-low-grade-glioma"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/d7d2fd821f87077daeef38311eebbe230514ccf3-1200x738.jpg?fit=crop&amp;auto=format" alt="FDA Approval | Image credit: wladimir1804 - stock.adobe.com" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">January 29th 2025</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-companion-diagnostic-for-tovorafenib-in-braf-altered-pediatric-low-grade-glioma">FDA Approves Companion Diagnostic for Tovorafenib in BRAF-Altered Pediatric Low-Grade Glioma</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/ashling-wahner">Ashling Wahner</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-companion-diagnostic-for-tovorafenib-in-braf-altered-pediatric-low-grade-glioma"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">Tovorafenib generated durable drug holiday responses in pediatric patients with BRAF-altered relapsed/refractory low-grade glioma.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/fda-expands-semaglutide-use-for-cv-kidney-risks-in-t2d-ckd"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/a5d351e64efb13433b50de220709d3d9d11705d2-4610x3254.jpg?fit=crop&amp;auto=format" alt="FDA approval | image credit: Aquir - stock.adobe.com" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">January 28th 2025</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/fda-expands-semaglutide-use-for-cv-kidney-risks-in-t2d-ckd">FDA Expands Semaglutide Use for CV, Kidney Risks in T2D, CKD</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/kyle-munz">Kyle Munz</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/fda-expands-semaglutide-use-for-cv-kidney-risks-in-t2d-ckd"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">The latest semaglutide (Ozempic; Novo Nordisk) approval is set to tackle a major need for patients with both type 2 diabetes (T2D) and chronic kidney disease (CKD), addressing their cardiovascular (CV) and kidney disease risks. </div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/treosulfan-regimen-approved-for-allohsct-conditioning-in-aml-mds"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/b0002ea79080e3493345e3c993b00be4690f0087-4279x2706.jpg?fit=crop&amp;auto=format" alt="FDA approved. | Image Credit: Pawel - stock.adobe.com" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">January 23rd 2025</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/treosulfan-regimen-approved-for-allohsct-conditioning-in-aml-mds">Treosulfan Regimen Approved for Allo-HSCT Conditioning in AML/MDS</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/rose-mcnulty">Rose McNulty</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/treosulfan-regimen-approved-for-allohsct-conditioning-in-aml-mds"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">The FDA approved treosulfan in combination with fludarabine as preparation for allogeneic hematopoietic stem cell transplantation (allo-HSCT) in adult and pediatric patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). </div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/esketamine-approved-by-fda-as-first-monotherapy-for-treatment-resistent-depression"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/b0002ea79080e3493345e3c993b00be4690f0087-4279x2706.jpg?fit=crop&amp;auto=format" alt="FDA approved. | Image Credit: Pawel - stock.adobe.com" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">January 21st 2025</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/esketamine-approved-by-fda-as-first-monotherapy-for-treatment-resistent-depression">Esketamine Approved by FDA as First Monotherapy for Treatment-Resistent Depression</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/giuliana-grossi">Giuliana Grossi</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/esketamine-approved-by-fda-as-first-monotherapy-for-treatment-resistent-depression"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">Esketamine (Spravato; Johnson &amp; Johnson) is now the first and only monotherapy for adults with major depressive disorder (MDD) with inadequate response to at least 2 oral antidepressants.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex md:hidden justify-center items-center"></div><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/fda-grants-2-traditional-approvals-for-acalabrutinib"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/d7d2fd821f87077daeef38311eebbe230514ccf3-1200x738.jpg?fit=crop&amp;auto=format" alt="FDA approval | Image Credit: © wladimir1804 - stock.adobe.com" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">January 17th 2025</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/fda-grants-2-traditional-approvals-for-acalabrutinib">FDA Grants 2 Traditional Approvals for Acalabrutinib</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/maggie-l-shaw">Maggie L. Shaw</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/fda-grants-2-traditional-approvals-for-acalabrutinib"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">The Bruton tyrosine kinase inhibitor was approved in combination with bendamustine and rituximab in previously untreated mantle cell lymphoma (MCL) ineligible for autologous hematopoietic stem cell transplantation and as monotherapy in previously treated MCL.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-sotorasib-plus-panitumumab-for-kras-g12c-mutated-metastatic-crc"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/407d27c5fd74836a18293620e5dbacab64d631cd-2000x2000.jpg?fit=crop&amp;auto=format" alt="FDA Approved" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">January 17th 2025</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-sotorasib-plus-panitumumab-for-kras-g12c-mutated-metastatic-crc">FDA Approves Sotorasib Plus Panitumumab for KRAS G12C-Mutated Metastatic CRC</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/julia-bonavitacola">Julia Bonavitacola</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-sotorasib-plus-panitumumab-for-kras-g12c-mutated-metastatic-crc"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">The combination treatment specifically targets KRAS-mutated metastatic colorectal cancer (CRC) to improve progression-free survival.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div><div><div class="text-[8px] text-center text-gray-500 hidden">Advertisement</div><div id="div-gpt-ad-infeed-19"></div></div></div><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-tislelizumab-jsgr-as-first-line-therapy-for-her2-gastric-cancers"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/504d2d94cf61879727ad2313dbe018741c0aef00-3600x2400.jpg?fit=crop&amp;auto=format" alt="gastric cancer | Image credit: Crystal light - stock.adobe.com" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">January 2nd 2025</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-tislelizumab-jsgr-as-first-line-therapy-for-her2-gastric-cancers">FDA Approves Tislelizumab-jsgr as First-Line Therapy for HER2– Gastric Cancers</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/skylar-jeremias">Skylar Jeremias</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-tislelizumab-jsgr-as-first-line-therapy-for-her2-gastric-cancers"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">Tislelizumab-jsgr (Tevimbra) was approved in combination with chemotherapy for the treatment of unresectable or metastatic HER2-negative (HER–) gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults whose tumors express PD-L1.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/5-key-drug-approvals-and-crls-in-2024"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/b0002ea79080e3493345e3c993b00be4690f0087-4279x2706.jpg?fit=crop&amp;auto=format" alt="Paper with FDA approved on top of a magnifying glass and a keyboard | Image Credit: Pawel - stock.adobe.com" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">December 27th 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/5-key-drug-approvals-and-crls-in-2024">5 Key Drug Approvals and CRLs in 2024</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/laura-joszt">Laura Joszt, MA</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/5-key-drug-approvals-and-crls-in-2024"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">In 2024, multiple drugs received complete response letters (CRLs), sometimes unrelated to the safety and efficacy of the drug, but patients with schizophrenia gained the first new treatment with a new mechanism of action in decades.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/first-subcutaneous-prophylaxis-for-hemophilia-a-and-b-with-inhibitors-approved-by-fda"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/9218bd8ec17bcbd1f819d87da6b7afbff7b24fdf-1200x738.jpg?fit=crop&amp;auto=format" alt="FDA-Deni-stock.adobe.com" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">December 23rd 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/first-subcutaneous-prophylaxis-for-hemophilia-a-and-b-with-inhibitors-approved-by-fda">First Subcutaneous Prophylaxis for Hemophilia A and B With Inhibitors Approved by FDA</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/giuliana-grossi">Giuliana Grossi</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/first-subcutaneous-prophylaxis-for-hemophilia-a-and-b-with-inhibitors-approved-by-fda"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">The approval of concizumab-mtci (Alhemo) injection marks a significant milestone in managing hemophilia A and B with inhibitors by preventing or reducing bleeding episodes in adults and children 12 years and older.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-first-generic-daily-glp-1-injection-for-type-2-diabetes"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/b0002ea79080e3493345e3c993b00be4690f0087-4279x2706.jpg?fit=crop&amp;auto=format" alt="FDA Approves First Generic Daily GLP-1 Injection for Type 2 Diabetes" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">December 23rd 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-first-generic-daily-glp-1-injection-for-type-2-diabetes">FDA Approves First Generic Daily GLP-1 Injection for Type 2 Diabetes</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/rose-mcnulty">Rose McNulty</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-first-generic-daily-glp-1-injection-for-type-2-diabetes"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">The approval marks the second for a generic in this class of medications indicated to improve glycemic control in patients with type 2 diabetes as a complement to diet and exercise.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/fda-rejects-sotagliflozin-for-type-1-diabetes-lexicon-shifts-focus"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/ebfb40d061db8cb94776018fe5f4c50f7871539b-5293x3529.jpg?fit=crop&amp;auto=format" alt="FDA website | Image credit: Postmodern Studio – stock.adobe.com" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">December 20th 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/fda-rejects-sotagliflozin-for-type-1-diabetes-lexicon-shifts-focus">FDA Rejects Sotagliflozin for Type 1 Diabetes; Lexicon Shifts Focus</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/hayden-e-klein">Hayden E. Klein</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/fda-rejects-sotagliflozin-for-type-1-diabetes-lexicon-shifts-focus"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">The FDA issued a complete response letter for sotagliflozin (Zynquista) as an adjunct to insulin therapy for glycemic control.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-encorafenib-with-cetuximab-and-mfolfox6-for-metastatic-crc"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/407d27c5fd74836a18293620e5dbacab64d631cd-2000x2000.jpg?fit=crop&amp;auto=format" alt="FDA Approved" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">December 20th 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-encorafenib-with-cetuximab-and-mfolfox6-for-metastatic-crc">FDA Approves Encorafenib With Cetuximab and mFOLFOX6 for Metastatic CRC</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/julia-bonavitacola">Julia Bonavitacola</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-encorafenib-with-cetuximab-and-mfolfox6-for-metastatic-crc"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">Patients with the BRAF V600E mutation and metastatic colorectal cancer (CRC) can be treated with a combination of encorafenib with cetuximab and mFOLFOX6.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div><div><div class="text-[8px] text-center text-gray-500 hidden">Advertisement</div><div id="div-gpt-ad-infeed-25"></div></div></div><div class="jsx-ad50481d5ee26850 flex md:hidden justify-center items-center"></div><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-seventh-ustekinumab-biosimilar-to-reference-stelara"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/ca845f7e6dfc35ab2f006b74744bb6c3a34fff11-5500x4093.jpg?fit=crop&amp;auto=format" alt="FDA approval with stamp. | Image Credit: Surendra - stock.adobe.com" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">December 20th 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-seventh-ustekinumab-biosimilar-to-reference-stelara">FDA Approves Seventh Ustekinumab Biosimilar to Reference Stelara</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/cameron-santoro">Cameron Santoro</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/fda-approves-seventh-ustekinumab-biosimilar-to-reference-stelara"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">The FDA granted approval to Steqeyma (ustekinumab-stba) for inflammatory conditions, making it the seventh biosimilar to reference Stelara after a year of multiple ustekinumab biosimilar approvals.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/ensartinib-receives-fda-approval-for-alk-positive-locally-advanced-or-metastatic-nsclc"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/b0002ea79080e3493345e3c993b00be4690f0087-4279x2706.jpg?fit=crop&amp;auto=format" alt="FDA approval. | Image Credit: Pawel - stock.adobe.com" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">December 19th 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/ensartinib-receives-fda-approval-for-alk-positive-locally-advanced-or-metastatic-nsclc">Ensartinib Receives FDA Approval for ALK-Positive Locally Advanced or Metastatic NSCLC</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/cameron-santoro">Cameron Santoro</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/ensartinib-receives-fda-approval-for-alk-positive-locally-advanced-or-metastatic-nsclc"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">The FDA has approved ensartinib in adult patients with anaplastic lymphoma kinase (ALK)–positive locally advanced or metastatic non–small cell lung cancer (NSCLC) naive to ALK treatment.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/fda-rejects-subcutaneous-amivantamab-for-nsclc-over-manufacturing-concerns"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/1b0ea624bff10262e2da3d5ec75d235207a08adc-1200x630.jpg?fit=crop&amp;auto=format" alt="Syringe and vials | Image credit: Aliaksandr Marko – stock.adobe.com" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">December 17th 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/fda-rejects-subcutaneous-amivantamab-for-nsclc-over-manufacturing-concerns">FDA Rejects Subcutaneous Amivantamab for NSCLC Over Manufacturing Concerns</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/hayden-e-klein">Hayden E. Klein</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/fda-rejects-subcutaneous-amivantamab-for-nsclc-over-manufacturing-concerns"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">Subcutaneous amivantamab joins a growing list of drugs receiving complete response letters due to manufacturing facility issues.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/cosibelimab-approved-for-metastatic-or-locally-advanced-cutaneous-squamous-cell-carcinoma"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/3deabc81aa93f0e49190012e256a274872b958e8-4363x3438.jpg?fit=crop&amp;auto=format" alt="FDA approved stamp in black with a red ribbon across it | Image credit: BHM - stock.adobe.com" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">December 16th 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/cosibelimab-approved-for-metastatic-or-locally-advanced-cutaneous-squamous-cell-carcinoma">Cosibelimab Approved for Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/kristi-rosa">Kristi Rosa</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/cosibelimab-approved-for-metastatic-or-locally-advanced-cutaneous-squamous-cell-carcinoma"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">The FDA has approved cosibelimab-ipdl for the treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or radiation.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/durvalumab-approval-redefines-resectable-nsclc-treatment-strategies"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/1ec091ec5293e43b6addd5389b5c28855d74083a-2549x1426.png?fit=crop&amp;auto=format" alt="Martin Dietrich, MD, PhD" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">December 13th 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/durvalumab-approval-redefines-resectable-nsclc-treatment-strategies">Durvalumab Approval Redefines Resectable NSCLC Treatment Strategies</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/hayden-e-klein">Hayden E. Klein</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/durvalumab-approval-redefines-resectable-nsclc-treatment-strategies"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">Martin Dietrich, MD, PhD, discusses how the FDA-approved combination therapy is transforming care for resectable early-stage non–small cell lung cancer (NSCLC).</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div><div class="jsx-ad50481d5ee26850 w-full h-full"><div class="jsx-ad50481d5ee26850 flex flex-col sm:flex-row justify-between my-4 "><a class="jsx-ad50481d5ee26850" href="/view/next-gen-strategies-for-resistance-in-egfr-mutated-lung-cancer"><img src="https://cdn.sanity.io/images/0vv8moc6/ajmc/398f81181f2692ac562b24bc01c26f9ba8dd0284-1200x675.jpg?fit=crop&amp;auto=format" alt="Joshua K. Sabari, MD, NYU Langone Perlmutter Cancer Center" width="288" class="jsx-ad50481d5ee26850 max-h-[200px] xs:w-[288px] "/></a><div class="jsx-ad50481d5ee26850 article-detail flex flex-col gap-[0.2rem] w-full sm:w-[46%] md:w-[65%]"><span class="jsx-ad50481d5ee26850 article-publish-date block italic text-sm text-gray-500 mt-[1rem] sm:mt-0">December 13th 2024</span><p class="jsx-ad50481d5ee26850 article-title font-bold text-[1rem]"><a class="jsx-ad50481d5ee26850" href="/view/next-gen-strategies-for-resistance-in-egfr-mutated-lung-cancer">Next-Gen Strategies for Resistance in EGFR-Mutated Lung Cancer</a></p><div class="jsx-ad50481d5ee26850 authors flex-row wrap gap-[0.2rem]"><a class="jsx-ad50481d5ee26850 text-[#00ADEF] underline text-sm italic" href="/authors/maggie-l-shaw">Maggie L. Shaw</a></div><div class="jsx-ad50481d5ee26850 article-summary"><a class="jsx-ad50481d5ee26850" href="/view/next-gen-strategies-for-resistance-in-egfr-mutated-lung-cancer"><div class="jsx-ad50481d5ee26850 text-sm text-gray-500 py-1">To conclude our interview with Joshua K. Sabari, MD, which focused on the approval of amivantamab plus lazertinib in the first line, he looks ahead to potential uses that could help to overcome treatment resistance in non–small cell lung cancer.</div></a></div></div></div><div style="border-bottom:1px solid #CCCCCC" class="jsx-ad50481d5ee26850"></div></div></div><div class="mt-4"><div class="w-full text-center flex justify-center pb-24"><a class="px-4 py-2 border-y border-r bg-primary text-white" href="/approvals-launches?page=1">1</a><a class="px-4 py-2 border-y border-r " href="/approvals-launches?page=2">2</a><a class="px-4 py-2 border-y border-r " href="/approvals-launches?page=3">3</a><a class="px-4 py-2 border-y border-r " href="/approvals-launches?page=4">4</a><a class="px-4 py-2 border-y border-r " href="/approvals-launches?page=5">5</a><a class="px-4 py-2 border-y border-r " href="/approvals-launches?page=6">6</a><a class="px-4 py-2 border-y border-r " href="/approvals-launches?page=7">7</a><a class="px-4 py-2 border-y border-r " href="/approvals-launches?page=8">8</a><div class="px-4 py-2 border-y border-r">...</div><a class="px-4 py-2 border-y border-r" href="/approvals-launches?page=11">11</a><a class="px-4 py-2 border-y border-r" href="/approvals-launches?page=2">&gt;</a></div></div></div></div><div class="flex-none w-[300px] z-[9999] relative hidden md:block"><div style="top:5rem" class="sticky custom-spacing"><div class="collapse-container " style="overflow:hidden;max-height:900px;transition:max-height .4s ease-in-out"></div></div></div></div><div id="div-gpt-ad-pixel" style="width:1px;height:1px" class=""></div><noscript><iframe src="https://www.googletagmanager.com/ns.html?id=GTM-NK5KQXS" height="0" width="0" style="display:none;visibility:hidden"></iframe></noscript><div id="footerOuterWrap" class=" mx-auto flex"><div class="bg-[#00598D] xl:w-[70%] w-[70%] py-12 pl-auto"><div class="xxl:w-[75%] w-[90%] ml-auto"><div><span 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