Replimune’s RP1+nivolumab melanoma BLA faces an FDA decision by Apr 10, 2026. The current cash runway extends to Q1'27. See ...
Regenerative Medicine Advanced Therapy (RMAT) designation requests update submitted to FDA with recent biomarker data ...
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 ...
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 ...
STAAR study demonstrated positive mean annualized estimated glomerular filtration rate (eGFR) slope at 52-weeks across all dosed patients in the study, which U.S. Food and Drug Administration (FDA) ...
Company expects up to six-month review period per FDA guidelines New longer-term clinical data demonstrating durable positive ...
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 ...
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MRNA down nearly 10% as FDA refuses to review influenza vaccine BLA
Moderna MRNA shares plunged around 10% in after-hours trading following the announcement that the FDA’s Center for Biologics Evaluation and Research (CBER) has issued a Refusal-to-File (RTF) letter ...
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