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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...[ Price : $8.95]
FDA accepts for review an Akebia Therapeutics NDA resubmission for vadadustat for treating anemia due to chronic kidney disease in...[ Price : $8.95]
BioXcel Therapeutics says an independent data integrity audit of a TRANQUILITY II clinical trial site that was the subject of an F...[ Price : $8.95]
FDA commissioner Robert Califf posts a positive report on his recent visit to India and the work he says that the countrys governm...[ Price : $8.95]
FDA publishes a draft guidance to assist ANDA applicants in demonstrating the bioequivalence of topical corticosteroids.[ Price : $8.95]
FDA approves a new indication for Servier Pharmaceuticals Tibsovo to treat adults with some myelodysplastic syndromes as detected ...[ Price : $8.95]
FDA releases the form FDA-483 with four observations from an inspection at Switzerlands UCB Farchim drug manufacturing facility.[ Price : $8.95]
Hyman, Phelps & McNamara attorney Dara Levy says FDA is taking a new approach to off-label presentations in a new draft guidance.