{"id":474193,"date":"2026-02-17T17:18:09","date_gmt":"2026-02-17T17:18:09","guid":{"rendered":"https:\/\/www.newsbeep.com\/us\/474193\/"},"modified":"2026-02-17T17:18:09","modified_gmt":"2026-02-17T17:18:09","slug":"disc-medicine-to-pursue-traditional-u-s-approval-after-fda-rejects-new-fast-track-route","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/us\/474193\/","title":{"rendered":"Disc Medicine to pursue traditional U.S. approval after FDA rejects new fast-track route"},"content":{"rendered":"\n<p class=\"yf-vbsvxt\">Feb 17 (Reuters) &#8211; Disc Medicine said \u200con Tuesday it \u200cwill pursue a traditional \u200bU.S. approval pathway for its rare disease drug \u200cafter \u2060the Food and Drug Administration \u2060declined to approve the treatment \u200bunder a \u200bnew \u200bfast-track review \u200cprogram. The drug, bitopertin, was previously reviewed under the FDA&#8217;s national priority voucher \u200cprogram, which \u200bfast-tracks \u200bthe \u200bprocess to \u200cone to two \u200bmonths \u200bfrom the typical 10-12 months.<\/p>\n<p class=\"yf-vbsvxt\">(Reporting \u200bby \u200cSiddhi Mahatole in Bengaluru; \u200bEditing by \u200bShailesh Kuber)<\/p>\n","protected":false},"excerpt":{"rendered":"Feb 17 (Reuters) &#8211; Disc Medicine said \u200con Tuesday it \u200cwill pursue a traditional \u200bU.S. approval pathway for&hellip;\n","protected":false},"author":2,"featured_media":474194,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[58],"tags":[195820,10474,97,243],"class_list":["post-474193","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medication","tag-fast-track","tag-food-and-drug-administration","tag-health","tag-medication"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/474193","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=474193"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/474193\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media\/474194"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media?parent=474193"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/categories?post=474193"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/tags?post=474193"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}