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

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The FDA is set to give its decision on SNY and REGN's sBLA for Dupixent for bullous pemphigoid by June 20, 2025.

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

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

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.

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 for priority review the supplemental biologics license application ...

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 ...

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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).