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FDA Accepts Biologics License for Proposed Biosimilar to Simponi
The U.S. FDA has accepted a Biologics License Application (BLA) for BAT2506, a proposed biosimilar to Simponi (golimumab).
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Ultragenyx Pharmaceuticals Gets CRL for UX111 Gene Therapy for MPS IIIA
Ultragenyx Pharmaceuticals RARE announced that the FDA has issued a Complete Response Letter (CRL) for its biologics license ...
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Nanoscope begins rolling submission of biologics license application for RP gene therapy
Nanoscope Therapeutics submitted the first modules of a biologics license application for MCO-010, an investigational gene ...
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FDA Rejects CAPR's Cell Therapy BLA for Genetic Disorder, Stock Tanks
Shares of Capricor Therapeutics CAPR tanked 33% on Friday after it announced that the FDA issued a complete response letter ( ...
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Capricor Therapeutics, Inc. (NASDAQ: CAPR) Securities Fraud Investigation; CAPR Investors Urged to Contact Award-Winning Firm, Gibbs Mura
What Should Capricor Therapeutics, Inc. Investors Do? If you invested in Capricor Therapeutics, Inc., visit our Capricor Terapeutics, Inc. Investigation webpage or call us at (888) 410-2925 to get ...
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FDA accepts new supplemental biologics license application for review for Winrevair
The FDA has accepted for priority review a new supplemental biologics license application for Winrevair to treat adults with ...