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GSK Seeking Expanded RSV Vaccine Use

[ Price : $8.95]

After reporting favorable study data in those aged 50-59 years, GSK says it will seek FDA approval for an expanded use of Arexvy (...

Info Collection on Public Health Projects

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Federal Register notice: FDA sends to OMB an information collection revision entitled Standardized Reporting Forms for FDA Federal...

CDER Made Erroneous Statements to A/C: Letter

[ Price : $8.95]

Three developers of the Intarcia Therapeutics ITCA 650 drug-device implantable product to improve glycemic control accuse CDER off...

Remote Interactive Evaluation Guidance

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FDA publishes a draft guidance describing its process for requesting and conducting voluntary remote interactive evaluations of so...

Medinol Gets OK on Latest Drug-Eluting Stent

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FDA approves Medinols EluNIR-PERL drug-eluting stent for treating coronary artery disease.

Denti.AI Dental Imaging Cleared

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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

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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...

Akebia Refiles Kidney Disease NDA

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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

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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...