PDUFA action date of July 22, 2025, with priority reviewWOBURN, Mass., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the ...
has accepted the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for patients with advanced melanoma. The FDA granted the BLA Priority Review ...
The biologics license application for RP1 (vusolimogene oderparepvec) plus nivolumab in advanced melanoma was accepted by the ...
Group announced that the U.S. Food and Drug Administration, FDA, has accepted the Biologics License Application, BLA, for RP1 ...
The investigational advanced melanoma combination therapy consisting of RP1 and nivolumab have a PDUFA action date of July 22 ...
The FDA has granted Priority Review to nipocalimab for the treatment of antibody positive patients with generalized myasthenia gravis.
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As Bora Biologics, the organization will continue to build upon its established reputation for quality and excellence in manufacturing while expanding its capabilities to meet the needs of biopharma ...
The FDA has accepted the BLA for lecanemab-irmb SC for weekly maintenance dosing in the treatment of early Alzheimer disease.
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