Two drugs developed by Disc Medicine (IRON) and Sanofi (SNY) are facing delays in their review timelines due to safety and ...

The timeline extension comes on the heels of the FDA requesting additional information to assess Filspari’s clinical benefit.

A plan to slash drug review times at the Food and Drug Administration is sparking deep concerns among agency staffers and ...

The U.S. Food and Drug Administration has delayed reviews of several drugs selected for the Trump administrations new ...

FDA delays drug reviews for two priority voucher drugs amid safety and efficacy concerns, extending timelines for Sanofi and Disc Medicine products.

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 ...

SOUTH SAN FRANCISCO, Calif., Oct. 13, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (DNLI) today announced that the U.S. Food and Drug Administration (FDA) has extended its review timeline of the ...

The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald ...

(RTTNews) - Denali Therapeutics Inc. (DNLI) on Monday announced that the U.S. Food and Drug Administration has extended its review timeline of the company's investigational therapeutic Tividenofusp ...

Dec 12 (Reuters) - Leaders at the U.S. Food and Drug Administration have pressed internally for reviewers to speed up their evaluation ‌of Eli Lilly's experimental weight‑loss pill, after the company ...

Top officials at the U.S. FDA have internally urged its reviewers to speed up the evaluation of Eli Lilly’s (LLY) marketing application for its weight loss pill orforglipron after the Indiana-based ...

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 ...