Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for review the resubmission of the supplemental Biologics License Application, or sBLA, for Dupixent to treat adults and pediatric ...
F8 formulation intended to replace EGRIFTA SV ® with simplified dosing for the treatment of excess abdominal fat in adults with HIV and lipodystrophy MONTREAL, Nov. 26, 2024 (GLOBE NEWSWIRE) -- ...
Ascendis Pharma (ASND) announced that the FDA has accepted for review its supplemental biologics license application, or sBLA, in adult growth hormone deficiency, or GHD, for TransCon hGH. The FDA set ...
Pfizer today announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review for the ...
Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activity More than 300,000 people in the US suffer from chronic spontaneous urticaria (CSU) that is ...
A Prescription Drug User Fee Act target date of June 20, 2025 has been set for the application. The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics ...
(NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the company’s supplemental Biologics License Application (sBLA) for HYMPAVZI ® ...
TOKYO, Oct. 22, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) accepted for ...
US FDA grants priority review status to Pfizer’s Hympavzi sBLA to treat two haemophilia A or B patient populations with significant medical need: New York Monday, February 9, 20 ...
If approved, marstacimab would be the first non-factor prophylactic treatment indicated for pediatric patients aged 6 to 11 years with hemophilia B.
Some results have been hidden because they may be inaccessible to you
Show inaccessible results