AM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to ...

ImmunityBio stock rose 19.8% after FDA meeting on ANKTIVA bladder cancer treatment. Company to submit additional data within ...

Prescription Drug User Fee Act (PDUFA) target action date set for June 29, 2026 If approved, ZORYVE cream 0.3% would be the first and only topical PDE4 inhibitor indicated for plaque psoriasis in ...

U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) target action date of May 22, 2025 Almost half of the 9 million individuals in the United States with plaque ...

WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer today announced the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for the oral ...

BEDMINSTER, N.J., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for ...

NASHVILLE, Tenn.--(BUSINESS WIRE)--Revance Therapeutics, Inc. (Nasdaq: RVNC) a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that it has submitted a ...

The FDA will review an application for Cabometyx as a potential treatment for pancreatic neuroendocrine tumors after findings from a phase 3 trial. A supplemental new drug application has been ...

NEW YORK & COPENHAGEN, Denmark--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and Genmab A/S (Nasdaq: GMAB) announced today that the U.S. Food and Drug Administration (FDA) has accepted the supplemental ...