FDA lifts a clinical hold against an Aprea Therapeutics clinical trial evaluating the combination of its lead compound, eprenetapopt, with acalabrutin...
FDA grants Pfizer and BioNTech an expanded emergency use authorization for their Covid-19 vaccine booster to include individuals 16 years of age and o...
FDA issues a draft guidance with recommendations for developing drugs or biological products to treat chronic rhinosinusitis with nasal polyps.
FDA issues a guidance with recommendations for the development of pediatric anti-infective drug products.
FDA approves a Thermo Fisher Scientific PMA for its Oncomine Dx Target Test as a companion diagnostic to help identify non-small cell lung cancer pati...
FDA warns Chicago-based Synaptent it is marketing unapproved and misbranded new drugs as dietary supplements.
FDA releases the FDA-483 with eight observations issued following an inspection at a Dr. Reddys sterile drug manufacturing facility in India.
Departing FDA interim commissioner Janet Woodcock identifies some priorities she hopes incoming commissioner Robert Califf will continue pursuing.