Florida officials ask a federal court to give FDA a bit longer to decide whether to approve a state plan to import some drugs from Canada for use in g...
FDA accepts for review an Akebia Therapeutics NDA resubmission for vadadustat for treating anemia due to chronic kidney disease in adult patients on d...
BioXcel Therapeutics says an independent data integrity audit of a TRANQUILITY II clinical trial site that was the subject of an FDA form FDA-483 repo...
FDA commissioner Robert Califf posts a positive report on his recent visit to India and the work he says that the countrys government and drug industr...
FDA releases the form FDA-483 with four observations from an inspection at Switzerlands UCB Farchim drug manufacturing facility.
Hyman, Phelps & McNamara attorney Dara Levy says FDA is taking a new approach to off-label presentations in a new draft guidance.
ResMed Ltd. recalls its Astral 100 and Astral 150 ventilators due to what FDA calls a device design issue.
FDA accepts for review an AstraZeneca supplemental BLA that seeks approval for a self- or caregiver-administered option for FluMist Quadrivalent, a ne...
