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...
Novo Nordisk petitions FDA to exclude its liraglutide from the agencys list of bulk drug substances that may be used by drug compounders.
FDA posts a six-item Form FDA-483 that led to a 12/19 Warning Letter to Mylan Laboratories citing its Pradesh, India manufacturing facility.
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 warns Indias Micro Orgo Chem about CGMP deviations in its production of active pharmaceutical ingredients.
