Legend Biotech files a supplemental BLA seeking to expand the label for Carvykti (ciltacabtagene autoleucel) to include the treatment of adult patient...
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.
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.
Federal Register notice: FDA withdraws approval of a Vintage Pharmaceuticals ANDA for pemoline tablets after the company requested its withdrawal.
