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 ...

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License ...

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

The FDA told Regeneron in a complete response letter that while it didn't identify any issues with the safety or efficacy of the drug in its approved indications and dosing regimens, the agency didn't ...

Approval based on Phase 3 trials demonstrating Dupixent significantly reduced itch and hives compared to placebo In the U.S., there are more than ...

Divi's Laboratories Limited has announced the signing of long-term manufacturing and supply agreement with a global pharma company for manufacturing and supply of advanced intermediates.

Dupixent approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria Approval based on phase 3 ...

USFDA, via email communication dated 11th April, 2025 (received by Medispray), has classified the inspection at the manufacturing facility of Medispray Laboratories Pvt Ltd as Voluntary Action ...

The FDA has accepted for Priority Review the sBLA for aflibercept injection 8mg for the treatment of macular edema following RVO and for monthly dosing in approved indications.