AbbVie Seeks FDA Approval for Etentamig in Myeloma Treatment
North Chicago, Illinois, USA, October 27, 2026 AbbVie has submitted a Biologics License Application (BLA) to the U.S. Food...
Biologics License Application
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Ocugen Gains Provisional Approval for OCU400 in The Bahamas
MALVERN, Pa. — September 25, 2026 Ocugen Inc. announced that its investigational modifier gene therapy OCU400 has received provisional...
Nanoscope’s MOGENRY BLA Accepted by FDA for Retinitis Pigmentosa
Dallas, Texas, USA, September 9, 2026 Nanoscope Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has...
Alvotech Wins FDA Review Acceptance for AVT80 Biosimilar
Reykjavik, Iceland – August 31, 2026 Alvotech announced that the U.S. FDA has accepted for review its Biologics License...
Bayer Reports Phase 3 PET Data in Cardiac Amyloidosis
Berlin, Germany, August 30, 2026 Bayer announced detailed results from the Phase 3 REVEAL study evaluating investigational PET radiotracer...
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AskBio Advances Heart Failure Gene Therapy in Phase 2
Durham, North Carolina, August 29, 2026 AskBio Inc. presented baseline characteristics from its Phase 2 GenePHIT clinical trial evaluating...
Moderna Wins FDA Approval for 2026-27 COVID Vaccines
Cambridge, Massachusetts, August 27, 2026 Moderna, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved supplemental...
Scholar Rock Advances Apitegromab FDA Review with Second Fill-Finish Facility
CAMBRIDGE, Mass., August 7, 2026 Scholar Rock announced that the U.S. Food and Drug Administration (FDA) review of its...
Annexon Reports Rapid GBS Responses with Tanruprubart in FORWARD Study
BRISBANE, Calif., August 6, 2026 Annexon, Inc. announced encouraging early clinical results from the ongoing FORWARD open-label study, with...
Vedanta Biosciences Secures $60M to Advance Phase 3 VE303
CAMBRIDGE, Mass., August 6, 2026 Vedanta Biosciences announced it has secured $60 million in funding to accelerate development of...
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