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.
FDA accepts for priority review a Bristol Myers Squibb NDA for iberdomide in combination with daratumumab and dexamethasone for patients with relapsed...
FDAs refusal to review Modernas mRNA influenza vaccine reignites concerns that vaccine policy particularly involving mRNA technology is becoming inc...
