AxoGen (NASDAQ:AXGN) executives outlined a year of accelerating commercial momentum, recent balance sheet improvements, and ...
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 ...
Discusses BLA Resubmission for Apitegromab in Spinal Muscular Atrophy and Regulatory Progress March 31, 2026 8:00 ...
Replimune Group’s REPL share price tumbled 54.2% over the past three months. The massive setback was observed after the FDA issued a complete response letter (CRL) in July, against the biologics ...
Rocket Pharmaceuticals RCKT announced that the FDA has accepted the resubmitted biologics license application (BLA) seeking approval for its gene therapy Kresladi (marnetegragene autotemcel; marne-cel ...
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, ...
(RTTNews) - Atara Biotherapeutics Inc. (ATRA) announced that the U.S. Food and Drug Administration issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) of EBVALLO ...
Deramiocel has the potential to become the first therapy to address both skeletal and cardiac manifestations of Duchenne muscular dystrophy BLA supported by positive pivotal HOPE-3 Phase 3 results, ...
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