Healthcare ❯ Regulatory Affairs

FDA

Vaccine Approval Vaccine Approval Process Clinical Trials Drug Approval Drug Approval Process Approval Process Emergency Use Authorization Fast Track Designation Drug Evaluation Food Recalls

Fulcrum Halts Pociredir Program After FDA Says PRC2 Inhibitors Carry Cancer Risk

FDA meeting minutes concluding a class-level malignancy signal removed a viable path for the EED-targeting sickle cell therapy.

Ironwood Sets 2026 Targets After LINZESS Price Cut as Shares Surge

FDA Expands Review of Possible COVID Vaccine-Linked Deaths to Multiple Age Groups

FDA Weighs Ending Pfizer COVID-19 Authorization for Children Under 5

FDA Lifts Pause on Valneva’s Chikungunya Vaccine for Seniors

FDA Shifts COVID-19 Vaccine Policy to Focus on High-Risk Groups