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The FDA declined approval of Darzalex Faspro for newly diagnosed, transplant-ineligible multiple myeloma in its current form.
Company expects to complete BLA submission in the fourth quarter of 2025NOVATO, Calif., Aug. 18, 2025 (GLOBE NEWSWIRE) -- ...
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has extended the target action dates to the fourth quarter of 2025 for two EYLEA HD® ...
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TipRanks on MSNUltragenyx Begins FDA Application for DTX401 Gene Therapy
Ultragenyx Pharmaceutical ( ($RARE) ) just unveiled an announcement. On August 18, 2025, Ultragenyx Pharmaceutical announced the start of a ...
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TipRanks on MSNRegeneron says FDA delayed review of two Eylea HD submissions
Pharmaceuticals announced that the Food and Drug Administration has extended the target action dates to Q4 of 2025 for two Eylea ...
In this Healio Video Perspective from the Retina World Congress, Huma Qamar, MD, MPH, of Ocugen, overviews programs for ...
Ingelheim: Boehringer Ingelheim has announced the signing of a contract development and manufacturing agreement with AnGes Inc. for the drug substance of AnGes' investigational treatment ...
Novavax, Inc. (NASDAQ:NVAX) is a biotechnology company focused on recombinant protein-based vaccines using nanoparticle and ...
Merck (MRK) announced the FDA has accepted the Biologics License Application, or BLA, for clesrovimab, the company’s investigational prophylactic long-acting monoclonal antibody designed to ...
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