FDA warns Greeces Rontis Hellas about Quality System and Medical Device Reporting violations in its production of a balloon catheter.
FDA approves Bristol Myers Squibbs Opdivo Qvantig subcutaneous injection for several cancer indications.
FDA approves Checkpoint Therapeutics Unloxcyt to treat some squamous cell cancer patients.
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.
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.
Axsome Therapeutics plans an NDA submission for AXS-05 (dextromethorphan-bupropion) in the second half of next year for treating Alzheimers disease ag...
