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Regeneron calls on FDA to develop two guidances to further the use of precision medicine in non-oncology diseases.[ Price : $8.95]
Glenmark Pharmaceuticals recalls (Class 1) 114 batches of potassium chloride extended-release capsules, USP (750 mg), due to disso...[ Price : $8.95]
A House subcommittee report claims that FDA cut corners in its usually rigorous processes and bowed to Biden Administration politi...[ Price : $8.95]
FDA sends AbbVie a second complete response letter on its NDA for ABBV-951 (for carbidopa/foslevodopa) for treating motor fluctuat...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Laboratory Developed Tests (LDTs): Small Entity Compliance ...[ Price : $8.95]
FDA accepts for review an Otsuka Pharmaceutical and H. Lundbeck supplemental NDA for Rexulti (brexpiprazole) in combination with s...[ Price : $8.95]
FDA approves Halozyme Therapeutics Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for treating chronic inflammatory de...[ Price : $8.95]
Federal Register notice: FDA announces a 7/22 public workshop entitled Best Practices for Meeting Management.