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

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 ...

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

The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab ...

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 ...

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

The US Food and Drug Administration (FDA) is expected to make a Prescription Drug User Fee Act (PDUFA) decision by mid-2025.

GSK plc (GSK, GSK.L) announced that the US Food and Drug Administration has accepted for review a Biologics License Application (BLA) ...

Theratechnologies (TSE:TH) has released an update. Don't Miss our Black Friday Offers: Theratechnologies has resubmitted a supplemental Biologics License Application to the FDA for its F8 formulation ...

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 ...

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