Nivolumab plus ipilimumab is being reviewed by the FDA as a first-line treatment for advanced colorectal cancer, with a ...

Bristol Myers' Opdivo plus Yervoy gets FDA Priority Review for first-line MSI-H/dMMR metastatic colorectal cancer, with a ...

The application was based on results from the three-arm Phase 3 CheckMate -8HW study.

Sanofi SNY and partner Regeneron REGN announced that the FDA has accepted their supplemental biologics license application ...

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for dupilumab to treat adults with bullous pemphigoid.

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This week, the European Commission granted approval to Merck’s MRK novel HIF-2α inhibitor, Welireg, for two indications. The ...

Dupixent sBLA accepted for FDA priority review for the targeted treatment of bullous pemphigoidIf approved, Dupixent would be the first and only ...

The US Food and Drug Administration (FDA) has accepted a supplemental biologics licence application (sBLA) for priority review, with a decision expected by 20 June 2025. If approved, Dupixent ...

Priority review is granted to regulatory applications seeking approval for therapies that have the potential to provide significant improvements in the treatment, diagnosis, or prevention of serious ...

Squibb announced that the U.S. FDA has accepted the supplemental biologics license application for Opdivo plus Yervoy as a ...

The US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults with bullous pemphigoid (BP).