Regulatory action was based on data from the Phase III QUASAR trial, which demonstrated that Eylea HD dosed every eight weeks ...

Pharmaceuticals announced that the U.S. Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application for EYLEA HD Injection 8 mg. The sBLA seeks ...

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for aflibercept injection 8mg for the treatment of macular edema following ...

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 ...

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 ...

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 ...

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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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