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Denti.AI Dental Imaging Cleared

[ Price : $8.95]

FDA clears a Denti.AI 510(k) for its Denti.AI Detect, which is described as a state-of-the-art imaging solution engineered to aid ...

FDA Decision on Florida Drug Imports Delayed: Report

[ Price : $8.95]

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...

Akebia Refiles Kidney Disease NDA

[ Price : $8.95]

FDA accepts for review an Akebia Therapeutics NDA resubmission for vadadustat for treating anemia due to chronic kidney disease in...

Positive Results from BioXcel Data Audit

[ 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...

Califf Positive on Visit to India

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FDA commissioner Robert Califf posts a positive report on his recent visit to India and the work he says that the countrys governm...

Dermatologic Corticosteroid BE Guidance

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FDA publishes a draft guidance to assist ANDA applicants in demonstrating the bioequivalence of topical corticosteroids.

FDA Approves New Tibsovo Indication

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FDA approves a new indication for Servier Pharmaceuticals Tibsovo to treat adults with some myelodysplastic syndromes as detected ...

UCB Farchim FDA-483 Released

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FDA releases the form FDA-483 with four observations from an inspection at Switzerlands UCB Farchim drug manufacturing facility.

FDA Changes Off-Label Approach: Attorney

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Hyman, Phelps & McNamara attorney Dara Levy says FDA is taking a new approach to off-label presentations in a new draft guidance.

ResMed Recalls Astral 100, 150 Ventilators

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ResMed Ltd. recalls its Astral 100 and Astral 150 ventilators due to what FDA calls a device design issue.