All FDA Approval News and Press Releases from PR Newswire

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The FDA's...</p> </div> <hr class="visible-xs-block visible-sm-block"/> </a> </div> </div> <div class="row newsCards" lang="en-US"> <div class="card col-view"> <a class="newsreleaseconsolidatelink display-outline w-100" href="/news-releases/first-and-only-treatment-for-chronic-hypoparathyroidism-approved-in-australia-302381167.html" role="group" aria-label="News Release"> <div class="col-sm-4 col-lg-3 col-xs-12 pull-right card"> <div class="img-parent-fixed img-thumbnail logo"> <div class="img-ratio-sizer"></div> <div class="img-ratio-element"> <img src="https://mma.prnewswire.com/media/1986460/Specialised_Therapeutics_Logo.jpg?w=300" alt="FIRST AND ONLY TREATMENT FOR CHRONIC HYPOPARATHYROIDISM APPROVED IN AUSTRALIA" title="FIRST AND ONLY TREATMENT FOR CHRONIC HYPOPARATHYROIDISM APPROVED IN AUSTRALIA" loading="lazy"/> </div> </div> </div> <div class="col-sm-8 col-lg-9 pull-left card"> <h3> <small>Feb 20, 2025, 11:01 ET</small> FIRST AND ONLY TREATMENT FOR CHRONIC HYPOPARATHYROIDISM APPROVED IN AUSTRALIA </h3> <p class="remove-outline">Independent biopharmaceutical company Specialised Therapeutics (ST) welcomes the registration of YORVIPATH® (palopegteriparatide) by the Therapeutic...</p> </div> <hr class="visible-xs-block visible-sm-block"/> </a> </div> </div> <div class="row newsCards" lang="en-US"> <div class="col-sm-12 card"> <a class="newsreleaseconsolidatelink display-outline w-100" href="/news-releases/naver-d2sf-backed-pranaq-receives-fda-510k-clearance-for-tiptraq-an-ai-enabled-home-sleep-apnea-test-302381045.html" role="group" aria-label="News Release"> <h3 class="no-top-margin remove-outline"> <small>Feb 20, 2025, 11:00 ET</small> NAVER D2SF-Backed PranaQ® Receives FDA 510(k) Clearance for TipTraQ, an AI-Enabled Home Sleep Apnea Test </h3> <p class="remove-outline">PranaQ, backed by NAVER D2SF continues to push the boundaries of AI-powered healthcare solutions. NAVER D2SF, NAVER's corporate venturing arm,...</p> <hr class="visible-xs-block visible-sm-block"/> </a> </div> </div> <div class="row newsCards" lang="en-US"> <div class="card col-view"> <a class="newsreleaseconsolidatelink display-outline w-100" href="/news-releases/atreon-orthopedics-announces-fda-510k-clearance-and-full-market-launch-of-biocharge-autobiologic-matrix-for-rotator-cuff-repair-302380953.html" role="group" aria-label="News Release"> <div class="col-sm-4 col-lg-3 col-xs-12 pull-right card"> <div class="img-parent-fixed img-thumbnail logo"> <div class="img-ratio-sizer"></div> <div class="img-ratio-element"> <img src="https://mma.prnewswire.com/media/2623681/PR_BioCharge2.jpg?w=300" alt="Atreon Orthopedics Announces FDA 510(k) Clearance and Full Market Launch of BioCharge® Autobiologic Matrix for Rotator Cuff Repair" title="Atreon Orthopedics Announces FDA 510(k) Clearance and Full Market Launch of BioCharge® Autobiologic Matrix for Rotator Cuff Repair" loading="lazy"/> </div> </div> </div> <div class="col-sm-8 col-lg-9 pull-left card"> <h3> <small>Feb 20, 2025, 08:14 ET</small> Atreon Orthopedics Announces FDA 510(k) Clearance and Full Market Launch of BioCharge® Autobiologic Matrix for Rotator Cuff Repair </h3> <p class="remove-outline">Atreon Orthopedics, LLC, a Columbus based innovator in tissue healing and regenerative technologies, announces the 510(k) clearance from the Food and ...</p> </div> <hr class="visible-xs-block visible-sm-block"/> </a> </div> </div> <div class="row newsCards" lang="en-US"> <div class="card col-view"> <a class="newsreleaseconsolidatelink display-outline w-100" href="/news-releases/clarity-receives-us-fda-fast-track-designation-for-the-treatment-of-metastatic-castration-resistant-prostate-cancer-patients-with-cu-67-sar-bispsma-302379766.html" role="group" aria-label="News Release"> <div class="col-sm-4 col-lg-3 col-xs-12 pull-right card"> <div class="img-parent-fixed img-thumbnail logo"> <div class="img-ratio-sizer"></div> <div class="img-ratio-element"> <img src="https://mma.prnewswire.com/media/1700068/Clarity_Large_Logo_high_res_ID_42691c6bc5c0_Logo.jpg?w=300" alt="Clarity receives US FDA Fast Track Designation for the treatment of metastatic castration-resistant prostate cancer patients with Cu-67 SAR-bisPSMA" title="Clarity receives US FDA Fast Track Designation for the treatment of metastatic castration-resistant prostate cancer patients with Cu-67 SAR-bisPSMA" loading="lazy"/> </div> </div> </div> <div class="col-sm-8 col-lg-9 pull-left card"> <h3> <small>Feb 19, 2025, 09:09 ET</small> Clarity receives US FDA Fast Track Designation for the treatment of metastatic castration-resistant prostate cancer patients with Cu-67 SAR-bisPSMA </h3> <p class="remove-outline">Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation...</p> </div> <hr class="visible-xs-block visible-sm-block"/> </a> </div> </div> <div class="row newsCards" lang="en-US"> <div class="card col-view"> <a class="newsreleaseconsolidatelink display-outline w-100" href="/news-releases/alphyn-secures-fda-clearance-of-investigational-new-drug-application-for-atopic-dermatitis-treatment-302379675.html" role="group" aria-label="News Release"> <div class="col-sm-4 col-lg-3 col-xs-12 pull-right card"> <div class="img-parent-fixed img-thumbnail logo"> <div class="img-ratio-sizer"></div> <div class="img-ratio-element"> <img src="https://mma.prnewswire.com/media/1899346/Alphyn_Biologics__LLC__Logo_Hi_Res_Transparent_Bckgrd_Logov1.jpg?w=300" alt="Alphyn Secures FDA Clearance of Investigational New Drug Application for Atopic Dermatitis Treatment" title="Alphyn Secures FDA Clearance of Investigational New Drug Application for Atopic Dermatitis Treatment" loading="lazy"/> </div> </div> </div> <div class="col-sm-8 col-lg-9 pull-left card"> <h3> <small>Feb 19, 2025, 07:30 ET</small> Alphyn Secures FDA Clearance of Investigational New Drug Application for Atopic Dermatitis Treatment </h3> <p class="remove-outline">Alphyn, a clinical-stage dermatology company developing first-in-class Multi-Target Therapeutics®, announced today that the U.S. Food and Drug...</p> </div> <hr class="visible-xs-block visible-sm-block"/> </a> </div> </div> <div class="row newsCards" lang="en-US"> <div class="col-sm-12 card"> <a class="newsreleaseconsolidatelink display-outline w-100" href="/news-releases/ptc-therapeutics-announces-fda-acceptance-and-priority-review-for-vatiquinone-nda-for-the-treatment-of-children-and-adults-with-friedreichs-ataxia-302379909.html" role="group" aria-label="News Release"> <h3 class="no-top-margin remove-outline"> <small>Feb 19, 2025, 07:00 ET</small> PTC Therapeutics Announces FDA Acceptance and Priority Review for Vatiquinone NDA for the Treatment of Children and Adults with Friedreich's Ataxia </h3> <p class="remove-outline">PTC Therapeutics, Inc. 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