FDA warns Fresh Nutrition it is selling misbranded and unapproved new human and animal drugs.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Daiichi Sankyos Turalio (pexidartinib).
FDA releases an FDA-483 with two observations from an inspection at Venus Concept.
New FDA-posted review documents provide more insight into how FDA reconciled using the accelerated approval pathway for Biogens Alzheimers drug Aduhel...
Two University of Connecticut professors say it will take a long time for FDA to recover from drug manufacturing inspections that couldnt be conducted...
The HHS Inspector General says the Center for Medicare and Medicaid Services should work with FDA and other partners to find the best way to address c...
The House Committee on Oversight and Select Subcommittee on the Coronavirus Crisis ask AstraZeneca and J&J for detailed information on their contracts...
FDAs Doran Fink says the agency will move quickly to add a Warning to Pfizer and Moderna Covid-19 vaccines about rare cases of myocarditis and pericar...