Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today announced that the U.S. Food & Drug ...

Summit Therapeutics (SMMT) stock jumps as the FDA accepts its marketing application for lead asset ivonescimab, a rival to ...

The FDA has set a Prescription Drug User Fee Act action date for 24 May 2026.

PARAMUS, N.J., May 14, 2025 /PRNewswire/ -- NS Pharma, Inc. (NS Pharma), a subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku) announced today that the U.S. Food and Drug Administration has ...

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced ...

Please provide your email address to receive an email when new articles are posted on . Phase 3 ZENITH trial data assessing Winrevair in adults with WHO functional class III or IV PAH support the new ...

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

WASHINGTON, Dec. 15, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug ...

FDA's release of CRLs for unapproved products does not appear to be limited to situations where the application's existence had been publicly disclosed or acknowledged. Based on our review of those ...

Savara Resubmits the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MOLBREEVI* for the Potential Treatment of Autoimmune Pulmonary Alveolar Proteinosis ...

Welcome to Alston & Bird’s introduction to biological products regulation. In this five-part intro-level series, we provide answers to a number ...

If approved, LEQEMBI IQLIK would be the first and only anti-amyloid treatment to offer at-home injection options for ...