FDA warns Miami, FL-based Dextrum Laboratories about CGMP violations in its production of finished drugs.
FDA approves an updated Boxed Warning for Janssen/Legend Biotechs Carvykti to state that secondary cancers have occurred in about 10% of patients rece...
FDA publishes an immediately effective guidance intended to expedite the reformulation of drug products containing carbomers manufactured with benzene...
FDA says Hospira recalled one lot of each of three injection products due to the possible presence of glass particulate matter.
FDA warns El Paso, TX-based Botanical Be about marketing products labeled as dietary supplements that legally are misbranded, unapproved new drugs tha...
FDA approves AutoGenomics AvertD test that uses DNA to assess individuals risk of developing opioid use disorder.
Aurobindo Pharma says FDA had 10 procedural observations from a pre-approval inspection at the firms new injectable facility in East Windsor, NJ.
FDA publishes an immediately effective guidance with its latest recommendations for submissions to support an emergency use authorization request for ...
