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 issues a complete response letter for Zealands glepaglutide intended to treat short bowel syndrome.
FDA warns a Viatris Mylan drug manufacturing facility in Pradesh, India, about CGMP violations involving quality and data issues.
FDA adds a liver injury Boxed Warning to labeling for Astellas menopause hot flash drug Veozah.
FDA says a Hologic 3/2024 recall correction of BioZorb Markers was Class 1.
