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...
ANDA
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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...
Par Health Launchs First FDA-Approved Generic Janumet® XR in U.S.
ST. LOUIS – July 24, 2026 Par Health, Inc. has announced the U.S. launch of its generic version of...
AbbVie Reports Positive Phase 3 Epcoritamab DLBCL Results
NORTH CHICAGO, Ill., June 29, 2026 AbbVie has announced positive topline results from the Phase 3 EPCORE® DLBCL-4 clinical...
FDA Selects Seven Firms for PreCheck Manufacturing Pilot
SILVER SPRING, Md., June 29, 2026 The U.S. Food and Drug Administration (FDA) has announced the selection of seven...
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Lupin Receives U.S. FDA Tentative Approval for Enzalutamide Tablets
MUMBAI, India & NAPLES, Fla., June 26, 2026 Lupin Limited announced that it has received tentative approval from the...
Transpire Bio Gains FDA Acceptance for High-Strength Generic Trelegy
SUNRISE, Fla., May 11, 2026 Transpire Bio Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted...
Apotex Secures FDA Approval for Infuvite Pediatric Injection
WESTON, FLORIDA, April 27, 2026 Apotex has secured U.S. Food and Drug Administration (FDA) approval for its generic Infuvite®...
DifGen, Apotex Win FDA Approval for Nintedanib Capsules
MIRAMAR, Fla., April 9, 2026 DifGen Pharmaceuticals LLC, in collaboration with Apotex Inc., has announced that the U.S. Food...
Cipla Wins FDA Approval for IPF Drug Nintedanib
MUMBAI, India and WARREN, N.J., April 3, 2026 Cipla USA Inc., a subsidiary of Cipla Limited, has received final...
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