{"id":249894,"date":"2025-09-23T21:12:14","date_gmt":"2025-09-23T21:12:14","guid":{"rendered":"https:\/\/www.europesays.com\/us\/249894\/"},"modified":"2025-09-23T21:12:14","modified_gmt":"2025-09-23T21:12:14","slug":"us-fda-declines-to-approve-higher-dose-of-biogens-genetic-disorder-drug","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/us\/249894\/","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":3,"featured_media":249895,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[26],"tags":[15102,6434,4373,815,132480,159,4375,132481,67,132,68],"class_list":{"0":"post-249894","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-genetics","8":"tag-biogen","9":"tag-food-and-drug-administration","10":"tag-genetic-disorder","11":"tag-genetics","12":"tag-progressive-muscle-weakness","13":"tag-science","14":"tag-spinal-muscular-atrophy","15":"tag-technical-information","16":"tag-united-states","17":"tag-unitedstates","18":"tag-us"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@us\/115255675625990176","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/249894","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/comments?post=249894"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/249894\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media\/249895"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media?parent=249894"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/categories?post=249894"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/tags?post=249894"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}