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 ...
Company expects up to six-month review period per FDA guidelines New longer-term clinical data demonstrating durable positive brain biochemical ...
Data support potential of isaralgagene civaparvovec as a one-time, well tolerated and durable Fabry disease gene therapy to provide meaningful, ...
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 ...
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 ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results