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Federal Register notice: FDA releases a revised draft guidance entitled Assessing the Irritation and Sensitization Potential of Transdermal and Topica...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 ...
GlaxoSmithKline asks the Supreme Court not to hear Tevas appeal of an adverse appeals court decision in a skinny label case for its generic form of GS...
