An FDA inspection cites multiple quality control and aseptic processing concerns at Staska Pharmaceuticals.
FDA posts updated guidance outlining how drugmakers should design clinical development programs for new tuberculosis treatments, emphasizing the need ...
FDA delays by three months its decision on Eisai and Biogen's subcutaneous starting-dose formulation of Alzheimers drug Leqembi (lecanemab) after the ...
A legal analysis published by Crowell & Moring says a proposed FDA pilot program on artificial intelligence in early-stage clinical trials could shape...
President Trump tells reporters he knows nothing about reports suggesting FDA commissioner Marty Makary will be asked to resign soon.
FDA seeks public input on ways to expand drug repurposing efforts, aiming to accelerate treatment options for patients with unmet medical needs by ide...
FDA issues updated guidance for companies developing therapies to treat, prevent or reduce recurrence of Clostridioides difficile infection (CDI), out...
FDA releases a new guidance outlining how drugmakers should design and conduct postapproval studies evaluating the safety of drugs and biologics used ...
