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

Johnson & Johnson has announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and ...

BALDWIN PARK, CA, USA I2, 2024 I StemCyte Inc., a wholly owned subsidiary of StemCyte International Ltd., announced today that the U.S. Food and ...

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

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 ...

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

The FDA accepts GSK's BLA seeking approval of Blenrep combinations for treating relapsed/refractory multiple myeloma. A decision is due on July 23, 2025.

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

Theratechnologies (NASDAQ:THTX) has resubmitted its supplemental Biologics License Application for a simplified dosing formulation of its drug tesamorelin for the reduction of excess abdominal fat in ...

The approval is supported by data from the COBLT study, FDA dockets and public information, and an observational database.

Resubmission addresses questions raised in January 2024 Complete Response Letter F8 formulation intended to replace EGRIFTA SV® with simplified dosing for the treatment of excess abdominal fat in ...