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FDA posts a six-item Form FDA-483 that led to a 12/19 Warning Letter to Mylan Laboratories citing its Pradesh, India manufacturing...[ Price : $8.95]
FDA alerts patients, caregivers, and healthcare providers to the potential for some Boston Scientific Accolade pacemakers to need ...[ Price : $8.95]
FDA approves Xcoverys Ensacove, an anaplastic lymphoma kinase inhibitor, to treat some non-small cell lung cancers.[ Price : $8.95]
FDA approves Humacytes Symvess for use with some extremity arterial injuries.[ Price : $8.95]
FDA issues a complete response letter for Zealands glepaglutide intended to treat short bowel syndrome.[ Price : $8.95]
FDA warns a Viatris Mylan drug manufacturing facility in Pradesh, India, about CGMP violations involving quality and data issues.[ Price : $8.95]
FDA adds a liver injury Boxed Warning to labeling for Astellas menopause hot flash drug Veozah.[ Price : $8.95]
FDA says a Hologic 3/2024 recall correction of BioZorb Markers was Class 1.