GoodRx reports that in 2025, novel drug and biosimilar approvals lag slightly behind last year, while first generic approvals ...

Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced that the U.S. Food and Drug ...

FDA accepts sNDA for Zoryve (roflumilast) cream 0.05% to treat mild to moderate atopic dermatitis in infants aged 3 to 24 months; PDUFA date set for Feb 2027.

The new findings position Lilly to file an application for the highly anticipated medicine, but also leave some questions ...

FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of February 23, 2027Application supported by positive results from Phase ...

FDA clearance of the IND, together with the previously cleared CTA, establishes a global Phase 1/2 clinical program for PM577a -- ...

(MNKD) was back in the spotlight on Friday as retail investors looked ahead to a crucial U.S. Food and Drug Administration ...

FDA sets PDUFA target action date of May 1, 2027 NEW YORK, July 15, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of ...

FDA’s rolling review process is intended to facilitate expedited review, enabling FDA to begin evaluating completed modules of the NDA before the full application is submitted FDA previously granted ...

WASHINGTON - The Food and Drug Administration has temporarily suspended a policy of publicly releasing letters explaining why ...

Marty Makary resigned as FDA commissioner amid controversy. But his reforms to drug review times and AI are the agency's ...

WESTLAKE VILLAGE, Calif., April 27, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in ...