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...
FDA clears a Moximed 510(k) for its MISHA Knee System, an implantable shock absorber for use in patients with medial knee osteoarthritis.
FDA posts a 13-page Form FDA-483 addressed to Lupin LTD. that cites significant GMP deficiencies from a 03/21-29 inspection.
Federal Register notice: FDA releases a revised draft guidance entitled Assessing the Irritation and Sensitization Potential of Transdermal and Topica...
FDA publishes a final guidance with recommendations for 510(k) submissions for peripheral percutaneous transluminal angioplasty balloon and specialty ...
