Ultragenyx Pharmaceutical Inc. announced the U.S. Food and Drug Administration (FDA or the Agency) has accepted for review the Biologics License Applicatio...
Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submissions for lenacapa...
The US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application (sBLA) for Dupixent (dupilumab) t...
Navi Medical Technologies, a medical device company focused on pediatric healthcare innovation, proudly announces that its Neonav® ECG Tip Location Sys...
Rznomics announced on the 14th that its anticancer drug, RZ-001, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for t...
TAHO Pharmaceuticals announces positive preliminary results from the pivotal study of TAH3311, the world's first oral resolution film (ODF) of apixaban. Th...
GSK plc announced that the US Food and Drug Administration (FDA) has approved Penmenvy (Meningococcal Groups A, B, C, W, and Y Vaccine) for use i...
Theratechnologies Inc., a specialty biopharmaceutical company focused on the commercialization of innovative therapies that have the potential to redefine ...
Roche announced that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for an Evrysdi® (risdiplam...
Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for AD...
SpringWorks Therapeutics, Inc. a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced that the U.S. Food ...
Celltrion announced that the U.S. Food and Drug Administration (FDA) has approved AVTOZMA® (CT-P47, tocilizumab-anoh) in both an intravenous (IV) ...
Global biotechnology leader CSL announced the four-year results from the pivotal HOPE-B study confirming the long-term durability and safety of a one...
Regeneron Pharmaceuticals, Inc.announced the first presentation of positive results from the Phase 3 QUASAR trial investigating EYLEA HD® (afliber...
© 2025 Biopharma Boardroom. All Rights Reserved.
