Regeneron Pharmaceuticals has won U.S. Food and Drug Administration priority review for its application seeking expanded approval of its Eylea HD eye drug.

The US Food and Drug Administration (FDA) has granted priority review to AstraZeneca's supplemental biologics licence application (sBLA) for Imfinzi (durvalumab), a human monoclonal antibody ...

AstraZeneca has bought a priority review voucher (PRV) from Swedish biotech Sobi for $95 million, but isn’t revealing just yet what it intends to use it for. A PRV can be used to reduce an FDA ...

The application has been granted priority review with a PDUFA date set for August 31, 2025. The BLA submission is supported by data from the Phase 2 HOPE-2 and HOPE-2 open-label extension trials ...

Tolebrutinib regulatory submission accepted for priority review in the US for patients with multiple sclerosis If approved, tolebrutinib would be the first and only brain-penetrant BTK inhibitor ...

A Prescription Drug User Fee Act target date of September 22, 2025 has been set for the application. The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License ...

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The FDA has granted Priority Review to pegcetacoplan for the treatment of C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis.

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