AstraZeneca wins FDA priority review for Datroway in triple-negative breast cancer, while Saphnelo SC receives a complete ...
Zacks Investment Research on MSN
Ultragenyx Pharmaceutical resubmits UX111 BLA for Sanfilippo syndrome
Ultragenyx Pharmaceutical RARE announced the resubmission of its biologics license application (“BLA”) to the FDA seeking ...
Ivonescimab's BLA acceptance is a milestone for PD-1/VEGF bispecific antibodies in the U.S., potentially transforming ...
Zacks Investment Research on MSN
FDA accepts SMMT's application seeking approval for NSCLC drug
Summit Therapeutics SMMT announced that the FDA has accepted its biologics license application (BLA) seeking approval for ...
SHANGHAI and NANJING, China and PLEASANTON, Calif., Nov. 27, 2025 /PRNewswire/ -- IASO Biotechnology ("IASO Bio"), a commercial-stage biopharmaceutical company dedicated to the discovery, development, ...
The company raised its full-year 2025 revenue growth guidance to "at least 17% or revenue of at least $219 million." Gross margin guidance remains in the "range of 73% to 75%, inclusive of onetime ...
Recurrent respiratory papillomatosis (RRP) is a rare HPV-related disease of the respiratory tract with significant unmet need INO-3107 previously received Orphan Drug and Breakthrough Therapy ...
The U.S. Food and Drug Administration (FDA) on Monday extended the Prescription Drug User Fee Act (PDUFA) goal date for Axogen Inc.’s (NASDAQ:AXGN) Biologics License Application (BLA) for Avance Nerve ...
Data support potential of isaralgagene civaparvovec as a one-time, well tolerated and durable Fabry disease gene therapy to provide meaningful, ...
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