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 ...

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

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 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 ...

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

A Prescription Drug User Fee target date of September 28, 2025 has been assigned to the application. The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug ...

today announced the closing of the sale of its Rare Pediatric Disease Priority Review Voucher (PRV) for gross proceeds of $150 million. “We have reached another key milestone with the closing on ...

Sanofi (NASDAQ:SNY) said on Tuesday that the US FDA has granted priority review for the regulatory submission of tolebrutinib for the treatment of multiple sclerosis. According to the French ...

Kye Pharmaceuticals announced it has submitted a New Drug Submission, or NDS, to Health Canada for the regulatory review and approval of ...

Sanofi’s tolebrutinib has been accepted for priority review by the US Food and Drug Administration (FDA) to treat certain cases of multiple sclerosis (MS). The investigational drug has been granted ...

Apellis Pharmaceuticals has announced US FDA acceptance of the supplemental new drug application (sNDA) and the granting of priority review status to Empaveli (pegcetacoplan) to treat the rare and ...