FDA lifts a 12/2022-ordered clinical hold on Entrada Therapeutics Duchenne muscular dystrophy therapy ENTR-601-44 and provided authorization to begin ...
Former CDER director Patrizia Cavazzoni rejoins Pfizer as the companys chief medical officer.
FDA approves a Medtronic PMA for its BrainSense Adaptive deep brain stimulation and BrainSense Electrode Identifier for use in Parkinsons patients.
FDA moves over the weekend to rehire up to 300 scientists and reviewers who were terminated last week as part of the Trump Administrations cost-cuttin...
FDA tells Insmed that it does not currently plan to hold an advisory committee meeting to discuss the companys NDA for brensocatib for patients with n...
FDA accepts for priority review a Bristol Myers Squibb supplemental BLA for Opdivo (nivolumab) plus Yervoy (ipilimumab) for a first-line treatment opt...
Drug compounding operations sue FDA in northern Texas federal court, seeking an order to reverse the agency decision last week to remove semaglutide (...
FDA rejects an Invivyd request to expand the existing emergency use authorization for pre-exposure prophylaxis of Covid-19 EUA for Pemgarda (pemivibar...
