FDA posts a final guidance entitled ANDAs: Pre-Submission Facility Correspondence (PFC) Related to Prioritized Generic Drug Submissions.
Senators Bernie Sanders (I-VT) and Angus King (I-ME) introduce legislation that would ban direct-to-consumer drug advertising.
FDA schedules a 7/17 meeting of its Oncologic Drugs Advisory Committee to review and vote on a GSK BLA for Blenrep (belantamab mafodotin) for treating...
FDA says a Medtronic recall of specified Newport ventilators is Class 1.
The Associated Press reports that questions are being raised about some new members appointed to the CDC Advisory Committee on Immunization Practices ...
A recent FDA pre-license inspection of Capricor Therapeutics San Diego manufacturing facility for investigation cell therapy Deramiocel results in a F...
FDA approves a UroGen Pharma NDA for Zusduri (mitomycin intravesical solution) for adult patients with recurrent low-grade intermediate-risk non-muscl...
FDA clears a Viz.ai 510(k) for the Viz Subdural Plus, which the company describes as the first and only comprehensive solution for quantifying the siz...
