{"id":177186,"date":"2025-09-23T21:13:09","date_gmt":"2025-09-23T21:13:09","guid":{"rendered":"https:\/\/www.newsbeep.com\/us\/177186\/"},"modified":"2025-09-23T21:13:09","modified_gmt":"2025-09-23T21:13:09","slug":"us-fda-declines-to-approve-higher-dose-of-biogens-genetic-disorder-drug","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/us\/177186\/","title":{"rendered":"US FDA declines to approve higher dose of Biogen&#8217;s genetic disorder drug"},"content":{"rendered":"\n<p class=\"yf-1090901\">(Reuters) -The U.S. Food and Drug Administration has declined to approve a higher-dose version of Biogen&#8217;s drug for a rare genetic disorder that causes progressive muscle weakness, dealing a setback to the company&#8217;s efforts to strengthen its position in a competitive market, the company said on Tuesday.<\/p>\n<p class=\"yf-1090901\">The health regulator has requested an update to technical information on the drug, Spinraza, to be included in the Chemistry Manufacturing and Controls module of the company&#8217;s application, Biogen said.<\/p>\n<p class=\"yf-1090901\">The company did not immediately respond to Reuters&#8217; request for comment.<\/p>\n<p class=\"yf-1090901\">Spinraza was first approved in 2016 to treat spinal muscular atrophy, which is the leading inherited cause of infant death.<\/p>\n<p class=\"yf-1090901\">The FDA&#8217;s decision casts uncertainty over the company&#8217;s efforts to revitalize its spinal muscular atrophy franchise, which has been losing ground to newer, more convenient therapies.<\/p>\n<p class=\"yf-1090901\">(Reporting by Kamal Choudhury, Mariam Sunny and Siddhi Mahatole in Bengaluru; Editing by Krishna Chandra Eluri)<\/p>\n","protected":false},"excerpt":{"rendered":"(Reuters) -The U.S. Food and Drug Administration has declined to approve a higher-dose version of Biogen&#8217;s drug for&hellip;\n","protected":false},"author":2,"featured_media":177187,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[50],"tags":[105426,10474,4244,200,105427,79,78332,105428],"class_list":["post-177186","post","type-post","status-publish","format-standard","has-post-thumbnail","category-genetics","tag-biogen","tag-food-and-drug-administration","tag-genetic-disorder","tag-genetics","tag-progressive-muscle-weakness","tag-science","tag-spinal-muscular-atrophy","tag-technical-information"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/177186","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/comments?post=177186"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/177186\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media\/177187"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media?parent=177186"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/categories?post=177186"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/tags?post=177186"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}