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FDA sends Eli Lilly a complete response letter on its BLA for mirikizumab and its use for treating ulcerative colitis.[ Price : $8.95]
Federal Register notice: FDA makes available a revised draft guidance Assessing Adhesion With Transdermal and Topical Delivery Sys...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Peripheral Percutaneous Transluminal Angioplasty (PTA) and ...[ Price : $8.95]
The Supreme Court grants a Department of Justice-requested temporary stay of a lower courts 4/7 order that would have restricted t...[ Price : $8.95]
Five House Republicans write FDA commissioner Robert Califf about agency safeguards in place when questionable foreign-made generi...[ Price : $8.95]
FDA sends Alvotech a second complete response letter on its BLA for AVT02, a biosimilar candidate referencing AbbVies Humira (adal...[ Price : $8.95]
Solgenix says FDA is requiring an additional study to resolve a refuse-to-file letter it received for its HyBryte (synthetic hyper...[ Price : $8.95]
FDA clears a Moximed 510(k) for its MISHA Knee System, an implantable shock absorber for use in patients with medial knee osteoart...