U.S. FDA Approves StemCyte Biologics License Application for REGENECYTE™ Cord Blood Cell Therapy Product
StemCyte Inc., a wholly owned subsidiary of StemCyte International Ltd., announced today that the U.S. Food and Drug ...
Replimune: RPL1 BLA Submission Under AA Pathway Makes It A Must Watch
Replimune's BLA submission and promising pipeline drugs are set to impact the global melanoma therapeutics market. Read more ...
Omeros Updates Progress on Narsoplimab Biologics License Resubmission; Stock up Over 30% on News
Omeros ( OMER, Financials) announced progress toward resubmitting its biologics license application for narsoplimab, its ...
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Accelerated Approval Sought for RP1-Nivolumab Combo for Pretreated Melanoma
The FDA received a biologics license application for accelerated approval of RP1 plus nivolumab for advanced, pretreated ...
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FDA Receives BLA for RP1 and Nivolumab Combo in Advanced Melanoma
The FDA has received a biologics license application submission for RP1 plus nivolumab in patients with PD-1 ...
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U.S. FDA Approves StemCyte Biologics License Application for REGENECYTE™ Cord Blood Cell Therapy Product
has approved the Biologics License Application (BLA) for its HPC, Cord Blood product REGENECYTE™, a vital cord blood stem cell therapy for transplantation in patients with blood and immune ...
Replimune Group (NASDAQ: REPL) Submits Biologics License Application for RP1 in Combination with Nivolumab to FDA
On November 21, 2024, Replimune Group, Inc. (NASDAQ: REPL) made significant strides in the advancement of its lead product candidate, RP1. The company announced the submission of a biologics license ...
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U.S. FDA Approves StemCyte Biologics License Application for REGENECYTE™ Cord Blood Cell Therapy Product
REGENECYTE™ is an allogeneic hematopoietic stem cell therapy derived from human umbilical cord blood. It is approved for unrelated donor hematopoietic progenitor cell transplantation procedures ...