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class="taxonomy-header__image-container"><section class="taxonomy-menu"><div class="taxonomy-menu__title-wrapper"><h1 class="taxonomy-menu__title">TGA</h1></div></section></div></section><div id="breadcrumbs" class="breadcrumbs"><a class="" href="/">Home</a> » <a class="" href="/topics">Topics</a> » <a class="" href="https://www.bioworld.com/topics/402-regulatory">Regulatory</a> » TGA</div><section class="article-list-hz-l3 topic-featured-articles"> <ul class="article-list-hz-l3__items"> <li class="article-list-hz-l3__item"> <article class="article-list-hz-l3__article"><figure class="article-list-hz-l3__image "><a class="thumbnail-link" href="https://www.bioworld.com/articles/717744-eu-mdr-backlog-could-create-an-opportunity-for-australia"><img class="article-list-hz-l3__image-thumb" loading="lazy" src="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/EU-Medical-Device-Regulation-MDR.png?height=355&t=1622066814&width=640" alt="Eu medical device regulation mdr" /></a></figure><div class="article-list-hz-l3__details -has-image"><div class="article-list-hz-l3__meta"><div class="article-list-hz-l3__post-date">March 7, 2025</div><div class="article-list-hz-l3__author"><a class="article-list-hz-l3__author-link" href="/authors/49-tamra-sami"><span class="article-list-hz-l3__author-title-prefix">By </span><span class="article-list-hz-l3__author-name">Tamra Sami</span></a></div></div><h1 class="article-list-hz-l3__headline"><a class="article-list-hz-l3__article-title-link" href="https://www.bioworld.com/articles/717744-eu-mdr-backlog-could-create-an-opportunity-for-australia">EU MDR backlog could create an opportunity for Australia</a></h1><div class="article-list-hz-l3__teaser">A slow-down in EU medical device audits due to the long-delayed transition to the EU Medical Device Regulation is leading to increased applications to Australia as small businesses bypass Europe altogether.</div></div></article> </li> <li class="article-list-hz-l3__item"> <article class="article-list-hz-l3__article"><div class="article-list-hz-l3__details"><div class="article-list-hz-l3__meta"><div class="article-list-hz-l3__post-date">March 4, 2025</div><div class="article-list-hz-l3__author"><a class="article-list-hz-l3__author-link" href="/authors/49-tamra-sami"><span class="article-list-hz-l3__author-title-prefix">By </span><span class="article-list-hz-l3__author-name">Tamra Sami</span></a></div></div><h1 class="article-list-hz-l3__headline"><a class="article-list-hz-l3__article-title-link" href="https://www.bioworld.com/articles/717843-australias-tga-rejects-eisais-leqembi-again">Australia鈥檚 TGA rejects Eisai鈥檚 Leqembi again</a></h1><div class="article-list-hz-l3__teaser">Australia鈥檚 Therapeutic Goods Administration (TGA) has once again decided against approving Eisai Australia Pty Ltd.鈥檚 amyloid beta binder, Leqembi (lecanemab), for treating patients with mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's dementia.</div></div></article> </li> <li class="article-list-hz-l3__item"> <article class="article-list-hz-l3__article"><figure class="article-list-hz-l3__image "><a class="thumbnail-link" href="https://www.bioworld.com/articles/716995-tga-clears-csls-garadacimab-to-prevent-hereditary-angioedema"><img class="article-list-hz-l3__image-thumb" loading="lazy" src="https://www.bioworld.com/ext/resources/Stock-images/Regulatory/Wood-approved-stamp-red.png?height=355&t=1670969940&width=640" alt="Wood approved stamp red" /></a></figure><div class="article-list-hz-l3__details -has-image"><div class="article-list-hz-l3__meta"><div class="article-list-hz-l3__post-date">Feb. 4, 2025</div><div class="article-list-hz-l3__author"><a class="article-list-hz-l3__author-link" href="/authors/49-tamra-sami"><span class="article-list-hz-l3__author-title-prefix">By </span><span class="article-list-hz-l3__author-name">Tamra Sami</span></a></div></div><h1 class="article-list-hz-l3__headline"><a class="article-list-hz-l3__article-title-link" href="https://www.bioworld.com/articles/716995-tga-clears-csls-garadacimab-to-prevent-hereditary-angioedema">TGA clears CSL鈥檚 garadacimab to prevent hereditary angioedema</a></h1><div class="article-list-hz-l3__teaser">Australia鈥檚 Therapeutic Goods Administration (TGA) has approved CSL Ltd.鈥檚 Andembry (garadacimab) for preventing recurrent hereditary angioedema attacks, marking the first global approval for the drug that was discovered and developed in Australia by CSL scientists.</div></div></article> </li> </ul><a class="article-list-hz-l3__more-link" href="/articles/topic/488">Read More</a> </section><section class="page-taxonomies-show__product-event-container "><section class="topic-authors "> <h1 class="topic-authors__title"><a class="topic-authors__title-link" href="/authors">Authors</a></h1><ul class="topic-authors__items"> <li class="topic-authors__item"> <div class="topic-authors__details"><a class="topic-authors__author-link" href="/authors/49-tamra-sami">Tamra Sami</a></div> </li> <li class="topic-authors__item"> <div class="topic-authors__details"><a class="topic-authors__author-link" href="/authors/21-mark-mccarty">Mark McCarty</a></div> </li> <li class="topic-authors__item"> <div class="topic-authors__details"><a class="topic-authors__author-link" href="/authors/4-mari-serebrov">Mari Serebrov</a></div> </li> <li class="topic-authors__item"> <div class="topic-authors__details"><a class="topic-authors__author-link" href="/authors/20-holland-johnson">Holland Johnson</a></div> </li> <li class="topic-authors__item"> <div class="topic-authors__details"><a class="topic-authors__author-link" href="/authors/47-david-ho">David Ho</a></div> </li> </ul><a class="topic-authors__more-link" href="/authors">More Authors</a> </section></section><div class="page-taxonomies-show__bottom-container"></div></div></div><footer class="main-footer"><div class="main-footer__top"><nav id="footer-1" class="main-footer__nav"><div 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