FDA reverses course and agrees to review Moderna’s seasonal influenza mRNA vaccine after previously refusing to file the BLA.
An FDA perspective in the New England Journal of Medicine outlines the agency’s move away from requiring two pivotal trials for drug approval.
FDA reverses course and agrees to review Moderna’s seasonal influenza mRNA vaccine after previously refusing to file the BLA.
An FDA perspective in the New England Journal of Medicine outlines the agency’s move away from requiring two pivotal trials for drug approval.
FDA commissioner Marty Makary says the agency will step up enforcement against unlawful mass compounding of GLP-1 weight-loss drugs, pursue an aggressive agenda to move more medicines over the counter, and accelerate early-stage clinical trials in the U.S.
The Sedgwick Recall Index year-end report for 2025 finds that the number of medical device recalls dropped compared to 2024, while drug recalls were slightly up.
