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Federal Register notice: FDA makes available a revised draft guidance Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs.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 ...
FDA sends Alvotech a second complete response letter on its BLA for AVT02, a biosimilar candidate referencing AbbVies Humira (adalimumab), based on ma...
Solgenix says FDA is requiring an additional study to resolve a refuse-to-file letter it received for its HyBryte (synthetic hypericin) NDA for lympho...
