FDA warns Malaysias Furley Bioextracts about CGMP violations in its production of OTC drugs and manufacturing a misbranded unapproved new drug.
FDA warns Honduras Laboratorio Pharma International about significant CGMP violations in its manufacturing of OTC drugs and production of a misbranded...
The DC federal court says FDA failed to prepare a necessary regulatory flexibility analysis when it developed a Final Standard Memorandum of Understan...
FDA releases the Biosimilar User Fee Act reauthorization goal letter for FY 2023-2027.
FDA releases four medical device material safety summaries developed through a partnership with ECRI.
FDA approves an Exelixis NDA for Cabometyx (cabozantinib) for treating certain adult and pediatric patients 12 years of age and older with locally adv...
FDA approves an Incyte supplemental NDA for Jakafi (ruxolitinib) for treating chronic graft-versus-host disease after failure of one or two lines of s...
The Medical Imaging & Technology Alliance says an FDA draft guidance on medical device remanufacturing is not likely to be effective until the agency ...