FDA reverses course and agrees to review Modernas seasonal influenza mRNA vaccine after previously refusing to file the BLA.
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 s...
An FDA perspective in the New England Journal of Medicine outlines the agencys move away from requiring two pivotal trials for drug approval.
Eli Lilly says that combining its psoriasis biologic Taltz (ixekizumab) with obesity drug Zepbound (tirzepatide) led to significantly greater skin cle...
FDA accepts for review the Hansa Biopharma BLA for imlifidase to be used in kidney transplantation.
FDA commissioner Marty Makary says the agency will step up enforcement against unlawful mass compounding of GLP-1 weight-loss drugs, pursue an aggress...
Three Hyman, Phelps & McNamara attorneys call on FDA to be more consistently flexible in dealing with regulatory approvals of rare disease treatments.
The FDA Rare Disease Innovation Hub sets eight action items for 2026.
