FDA medical reviewers ask members of the Peripheral and Central Nervous System Drugs Advisory Committee to confirm the benefits and risks of Eisai/Bio...
FDA warns Houston, TX-based physician Mobeen Mazhar about violations in conducting three clinical trials.
Five Hogan Lovells attorneys explain how an FDA proposal to require Patient Medication Information would represent a significant change in drug labeli...
FDA approves Mercks Prevymis (letermovir) for prophylaxis of cytomegalovirus disease in adult kidney transplant recipients.
FibroGen says its pamrevlumab failed to meet the primary endpoint in treating Duchenne Muscular Dystrophy in a Phase 3 trial.
AdvaMed says it agrees with FDA on questions to be added to a guidance on the submission of patient preference information, and also recommends change...
Sen. Ron Wyden calls on FDA and the DEA to issue a joint statement on the current Adderall shortage and to answer questions about its work in addressi...
Federal Register notice: FDA makes available a final guidance entitled Cover Letter Attachments for Controlled Correspondence and ANDA Submissions.
