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...
Federal Register notice: FDA announces a 7/22 public workshop entitled Best Practices for Meeting Management.
Federal Register notice: FDA announces a publication containing modifications it is making to the list of standards FDA recognizes for use in premarke...
Federal Register notice: FDA determines that Janssen Pharmaceuticals Invega (paliperidone) extended-release tablet was not withdrawn from sale due to ...
FDA converts Janssens Sirturo (bedaquiline) from accelerated to traditional approval following a determination that a confirmatory trial verified clin...
