{"id":7638,"date":"2025-10-16T23:02:20","date_gmt":"2025-10-16T23:02:20","guid":{"rendered":"https:\/\/mailitics.com\/index.php\/2025\/10\/16\/fda-chaos-hurts-innovation-two-examples-replimune-capricor\/"},"modified":"2025-10-16T23:02:20","modified_gmt":"2025-10-16T23:02:20","slug":"fda-chaos-hurts-innovation-two-examples-replimune-capricor","status":"publish","type":"post","link":"https:\/\/mailitics.com\/index.php\/2025\/10\/16\/fda-chaos-hurts-innovation-two-examples-replimune-capricor\/","title":{"rendered":"STAT+: Biotech leaders say uncertainty at FDA threatens drug development"},"content":{"rendered":"

STAT+: Biotech leaders say uncertainty at FDA threatens drug development
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BOSTON \u2014 Replimune Group and Capricor Therapeutics both seemed on track to receive long-awaited drug approvals from the Food and Drug Administration earlier this year.\u00a0<\/p>\n

Then, amid tumult at the agency as the Trump administration took power, their applications were rejected. The companies\u2019 CEOs talked about the importance of a stable FDA at the STAT Summit<\/a> on Wednesday.<\/p>\n

\u201cIt is going to kill drug development if you don\u2019t have consistency and transparency,\u201d said Replimune CEO Sushil Patel. \u201cIt\u2019s really going to make it very difficult for us to bring innovative treatments to patients faster.\u201d<\/p>\n

Continue to STAT+ to read the full story\u2026<\/a><\/p>\n<\/div>\n

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\n Lizzy Lawrence
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\nGo to statnews<\/a>
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STAT+: Biotech leaders say uncertainty at FDA threatens drug development BOSTON \u2014 Replimune Group and Capricor Therapeutics both seemed on track to receive long-awaited drug approvals from the Food and Drug Administration earlier this year.\u00a0 Then, amid tumult at the agency as the Trump administration took power, their applications were rejected. The companies\u2019 CEOs talked […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2194,2154,2159,2208,2146,1428,2176,2155,2151,2144,2677,2152],"tags":[2150],"class_list":["post-7638","post","type-post","status-publish","format-standard","hentry","category-biotech","category-biotechnology","category-cancer","category-drug-development","category-fda","category-health","category-pharma","category-pharmaceuticals","category-policy","category-politics","category-stat-summit","category-stat","tag-statnews"],"_links":{"self":[{"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/posts\/7638"}],"collection":[{"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/comments?post=7638"}],"version-history":[{"count":0,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/posts\/7638\/revisions"}],"wp:attachment":[{"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/media?parent=7638"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/categories?post=7638"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/tags?post=7638"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}