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

REGENXBIO Inc. RGNX shares are lower during Tuesday's premarket session as the company faces challenges following a recent Complete Response Letter (CRL) from the U.S. Food and Drug Administration ...

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

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 ...

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

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, ...

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

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 ...

IASO Biotechnology has received the Hong Kong Department of Health's approval for its biologics licence application (BLA) for the fully human anti-B-cell maturation antigen (BCMA) chimeric antigen ...

(RTTNews) - Denali Therapeutics (DNLI) announced that the FDA has accepted for review the Biologics License Application seeking accelerated approval for tividenofusp alfa for the treatment of Hunter ...