Ultragenyx Pharmaceutical RARE announced the resubmission of its biologics license application (“BLA”) to the FDA seeking ...

Summit Therapeutics SMMT announced that the FDA has accepted its biologics license application (BLA) seeking approval for ...

Ivonescimab's BLA acceptance is a milestone for PD-1/VEGF bispecific antibodies in the U.S., potentially transforming ...

Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today announced that the U.S. Food & Drug ...

Company expects up to six-month review period per FDA guidelines New longer-term clinical data demonstrating durable positive brain biochemical ...

OS Therapies Inc. (NYSE American: OSTX) (“OS Therapies” or “the Company”), the world leader in listeria-based cancer ...

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, ...

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 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 ...