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 approves a Mirum Pharmaceuticals NDA for Ctexli (chenodiol) for treating adults with cerebrotendinous xanthomatosis.
Pharmaceutical Research and Manufacturers of America says FDA should revise its recommendations for sponsors requesting meetings concerning cellular a...
