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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.[ Price : $8.95]
Federal Register notice: FDA announces a publication containing modifications it is making to the list of standards FDA recognizes...[ Price : $8.95]
Federal Register notice: FDA determines that Janssen Pharmaceuticals Invega (paliperidone) extended-release tablet was not withdra...[ Price : $8.95]
FDA converts Janssens Sirturo (bedaquiline) from accelerated to traditional approval following a determination that a confirmatory...[ Price : $8.95]
FDA releases a guidance entitled Laboratory Developed Tests: Small Entity Compliance Guide.