Target action dates for drugs sponsored by Sanofi, Boehringer Ingelheim and Disc Medicine have also been pushed back despite ...
Two drugs developed by Disc Medicine (IRON) and Sanofi (SNY) are facing delays in their review timelines due to safety and ...
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates ...
Eli Lilly (LLY) shares slipped ~5% on Thursday, marking what could be its biggest intraday loss in five months after Reuters ...
FDA delays drug reviews for two priority voucher drugs amid safety and efficacy concerns, extending timelines for Sanofi and Disc Medicine products.
A plan to slash Food and Drug Administration drug review times is raising alarms at the public health agency that's been ...
The FDA has named the first nine medications selected for its national priority review voucher program, which aims to shorten drug review timelines to as fast as two months, according to an Oct. 16 ...
FDA grants AXS-05 Priority Review designation and sets PDUFA action goal date of April 30, 2026 NEW YORK, Dec. 31, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a ...
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Exclusive-US FDA Taps Merck Drugs With Blockbuster Sales Potential for National Priority Vouchers
Merck's cholesterol pill enlicitide decanoate and its cancer therapy sacituzumab tirumotecan, or sac-TMT, have been tapped ...
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