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 says semaglutide injection product shortages (Novo Nordisks Wegovy and Ozempic) are resolved.
Pfizer discontinues the marketing of its hemophilia B gene therapy Beqvez (fidanacogene elaparvovec-dzkt) due to limited patient and physician interes...
FDA accepts for priority review a Boehringer Ingelheim NDA for zongertinib (BI 1810631) for treating certain adult patients with unresectable or metas...
