Replimune's BLA submission and promising pipeline drugs are set to impact the global melanoma therapeutics market. Read more ...

SPRING HOUSE, PA – Johnson & Johnson (NYSE: JNJ) has submitted a supplemental Biologics License Application (sBLA) to the U.S ...

GSK plc GSK announced that the FDA accepted its biologics license application (BLA) seeking approval for the Blenrep ...

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 ( OMER, Financials) announced progress toward resubmitting its biologics license application for narsoplimab, its ...

The FDA has received a biologics license application submission for RP1 plus nivolumab in patients with PD-1 ...

StemCyte Inc., a wholly owned subsidiary of StemCyte International Ltd., announced today that the U.S. Food and Drug ...

Outlook Therapeutics (OTLK) announced preliminary topline results of Norse Eight, the second of two adequate and well controlled clinical ...

The FDA received a biologics license application for accelerated approval of RP1 plus nivolumab for advanced, pretreated ...

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 ...

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 ...

For patients with previously treated EGFR-mutated NSCLC, a new BLA has been submitted to the FDA seeking the accelerated ...