The FDA granted approval to nilotinib (Danziten) on November 14, 2024, for the treatment of adult patients with newly ...

Monday announced an agreement with Partner Therapeutics, Inc. to commercialize Zenocutuzumab for the treatment of ...

Ferring Announces U.S. FDA Advisory Committee Meeting for SI-6603 (condoliase), An Investigational Treatment in Lumbar Disc ...

The NRG1 gene encodes neuregulin (also known as heregulin), the ligand for HER3. Fusions between NRG1 and partner genes are ...

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

At least some of the losing applicants are expected to challenge the health agency’s decisions and lead to further delays.

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 ...

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) ...

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 ...

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