Advanced Medical Technology Association says there are inconsistencies and ongoing concerns with FDAs guidance on remanufacturing/servicing medical de...
Regeneron calls on FDA to develop two guidances to further the use of precision medicine in non-oncology diseases.
Glenmark Pharmaceuticals recalls (Class 1) 114 batches of potassium chloride extended-release capsules, USP (750 mg), due to dissolution concerns.
A House subcommittee report claims that FDA cut corners in its usually rigorous processes and bowed to Biden Administration political pressure in appr...
FDA sends AbbVie a second complete response letter on its NDA for ABBV-951 (for carbidopa/foslevodopa) for treating motor fluctuations in adults with ...
Federal Register notice: FDA makes available a final guidance entitled Laboratory Developed Tests (LDTs): Small Entity Compliance Guide.
FDA accepts for review an Otsuka Pharmaceutical and H. Lundbeck supplemental NDA for Rexulti (brexpiprazole) in combination with sertraline for treati...
FDA approves Halozyme Therapeutics Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for treating chronic inflammatory demyelinating polyneur...
