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

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

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

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

Outlook Therapeutics will resubmit a biologics license application for its ophthalmic formulation of bevacizumab early next year after the second of two clinical trials missed a key target. The ...

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 ...

Theratechnologies (THTX) announced the resubmission of its supplemental Biologics License Application, sBLA, to 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 ...

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 ...

London: GSK plc has announced the US Food and Drug Administration (FDA) has accepted for review a Biologics License ...

In the NORSE EIGHT trial, ONS-5010 did not meet the pre-specified non-inferiority endpoint at week 8 set forth in the special protocol assessment (SPA) with the U.S. Food and Drug Administration (FDA) ...