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 ...
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Johnson & Johnson Advances Ulcerative Colitis Treatment with FDA Filing for TREMFYA® Subcutaneous Regimen
SPRING HOUSE, PA – Johnson & Johnson (NYSE: JNJ) has submitted a supplemental Biologics License Application (sBLA) to the U.S ...
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FDA Accepts GSK's BLA for Blenrep Combos in Multiple Myeloma
GSK plc GSK announced that the FDA accepted its biologics license application (BLA) seeking approval for the Blenrep ...
Outlook Therapeutics Trial of Eye Disease Treatment Misses Key Endpoint
Outlook said it remains confident that ONS-5010, marketed as Lytenava in the EU, is an important therapy for the treatment of wet age-related macular degeneration in place of off-label repackaged ...
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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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 ...
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 ...
Omeros Shares Hit 52-Week High on Plan to Resubmit Narsoplimab Application
Shares of Omeros touched a 52-week high, a day after the company said it could resubmit its biologics license application for narsoplimab to the Food and Drug Administration. In Thursday afternoon ...
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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 ...
Outlook Therapeutics reports preliminary results from Norse Eight trials
Outlook Therapeutics (OTLK) announced preliminary topline results of Norse Eight, the second of two adequate and well controlled clinical ...
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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US FDA Accepts Biologics License Application (BLA) for HLX14, Biosimilar Candidate of PROLIA/XGEVA (denosumab)
has accepted the Biologic License Application (BLA) for HLX14, an investigational biosimilar of PROLIA/XGEVA (denosumab). Denosumab has been approved in various countries and regions under ...