A joint advisory committee meeting votes 9 to 1 that an Otsuka Pharmaceutical and Lundbeck a sNDA for Rexulti (brexpriprazole) provided sufficient dat...
FDA clears an Abbott 510(k) for a reader for its FreeStyle Libre 3 integrated continuous glucose monitoring system.
Avenue Therapeutics meets with FDA to map out a plan for resubmitting a twice-rejected NDA for intravenous tramadol for treating post-operative pain.
FDA sends Eli Lilly a complete response letter on its BLA for mirikizumab and its use for treating ulcerative colitis.
Federal Register notice: FDA makes available a revised draft guidance Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs.
Federal Register notice: FDA makes available a final guidance entitled Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters ...
The Supreme Court grants a Department of Justice-requested temporary stay of a lower courts 4/7 order that would have restricted the distribution of t...
Five House Republicans write FDA commissioner Robert Califf about agency safeguards in place when questionable foreign-made generic drugs are allowed ...
