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.
Lexicon stops development of its diabetes drug Zynquista that received an FDA complete response letter.
FDA says a Hologic 3/2024 recall correction of BioZorb Markers was Class 1.
UCB says it is ending the development of minzasolmin, a drug it was working on with Novartis to treat early Parkinsons disease, after the drug missed ...