NRx Pharmaceuticals Clears FDA ANDA Review
MIAMI, August 7, 2026 NRx Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has completed the first-cycle...
Drug Approval
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Lupin Boosts U.S. Generics Business with FDA Approval
MUMBAI, India, and NAPLES, Fla., July 28, 2026 Lupin Limited has received U.S. Food and Drug Administration (FDA) approval...
Viatris Wins U.S. FDA Approval for Gwyn Lo Contraceptive
PITTSBURGH, July 29, 2026 Viatris Inc. has received U.S. Food and Drug Administration (FDA) approval for Gwyn Lo™ (norelgestromin...
Otsuka Wins FDA Approval for First-in-Class SIMTRIYO for ADHD
PRINCETON, N.J. and TOKYO, Japan, July 24, 2026 Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd....
Vertanical’s Exilby Wins First European Approval for Chronic Pain
GRÄFELFING, Germany – June 9, 2026 VERTANICAL has achieved a major milestone in chronic pain treatment after receiving Germany’s...
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Apotex Wins Approval for DENOZA Biosimilar in Canada
TORONTO, Ontario, Canada, April 7, 2026 Apotex Inc., a leading global pharmaceutical company, announced that Health Canada has approved...
BioXcel IGALMI sNDA Accepted by FDA for At-Home Use
NEW HAVEN, Conn., USA — April 1, 2026 BioXcel Therapeutics, Inc. announced that the U.S. Food and Drug Administration...
FDA Approves LIB Therapeutics’ LEROCHOL™ for High LDL Cholesterol
WASHINGTON, D.C. — December 15, 2025 — LIB Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA)...
Novartis wins FDA approval for first oral BTKi in chronic urticaria
EAST HANOVER, N.J., Sept. 30, 2025 – Novartis today announced that the U.S. Food and Drug Administration (FDA) has...
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