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FDA warns Dr. Bertrand Cole in Portsmouth, NH, about failing to conduct a clinical study according to the investigational plan.[ Price : $8.95]
FDA reverses course and agrees to review Modernas seasonal influenza mRNA vaccine after previously refusing to file the BLA.[ Price : $8.95]
The Sedgwick Recall Index year-end report for 2025 finds that the number of medical device recalls dropped compared to 2024, while...[ Price : $8.95]
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...