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An FDA perspective in the New England Journal of Medicine outlines the agencys move away from requiring two pivotal trials for dru...[ Price : $8.95]
Eli Lilly says that combining its psoriasis biologic Taltz (ixekizumab) with obesity drug Zepbound (tirzepatide) led to significan...[ Price : $8.95]
FDA accepts for review the Hansa Biopharma BLA for imlifidase to be used in kidney transplantation.[ Price : $8.95]
FDA commissioner Marty Makary says the agency will step up enforcement against unlawful mass compounding of GLP-1 weight-loss drug...[ Price : $8.95]
Three Hyman, Phelps & McNamara attorneys call on FDA to be more consistently flexible in dealing with regulatory approvals of rare...[ Price : $8.95]
The FDA Rare Disease Innovation Hub sets eight action items for 2026.[ Price : $8.95]
FDA accepts for priority review a Bristol Myers Squibb NDA for iberdomide in combination with daratumumab and dexamethasone for pa...[ Price : $8.95]
FDAs refusal to review Modernas mRNA influenza vaccine reignites concerns that vaccine policy particularly involving mRNA technol...