CDER approves 50 novel products in 2024, five less than the 55 products approved in 2023 and well above the 10-year rolling annual average of 46 appro...
FDA posts a final guidance entitled Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the...
FDA issues a draft guidance entitled Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway.
FDA clears an Inogen 510(k) for the Simeox 200 Airway Clearance Device.
FDA recommends that consumers not purchase or use Rhino 11 gummies due to the presence of undeclared tadalafil.
FDA alerts patients, caregivers, and healthcare providers to the potential for some Boston Scientific Accolade pacemakers to need replacement early.
FDA approves Xcoverys Ensacove, an anaplastic lymphoma kinase inhibitor, to treat some non-small cell lung cancers.
FDA approves Humacytes Symvess for use with some extremity arterial injuries.
