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Dupixent sBLA Get Priority Review for COPD

[ Price : $8.95]

FDA accepts for priority review a Sanofi and Regeneron supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatmen...

Venatorx/Melinta Antibiotic Gets Complete Response

[ Price : $8.95]

FDA issues Venatorx Pharmaceuticals and Melinta Therapeutics a complete response letter on their NDA for cefepime-taniborbactam, a...

Bioporto Pediatric Kidney Injury Assay Cleared

[ Price : $8.95]

FDA clears a Bioporto 510(k) for its ProNephro AKI (NGAL) biomarker assay for detecting pediatric acute kidney injury.

FDA Denies Appeal; Pepaxto to be Withdrawn

[ Price : $8.95]

FDA rejects an Oncopeptides appeal seeking to stop a CBER request for the company to voluntarily withdraw its accelerated-approved...

FDA to Change Some Trial Registration Enforcement

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FDA says it has responded to a Universities Allied for Essential Medicines by creating a dashboard of Clinical Trials.gov pre-noti...

ClearPoint Brain Modeling Software Cleared

[ Price : $8.95]

FDA clears a ClearPoint Neuro 510(k) for use of its ClearPoint 2.2 software with the integrated Maestro Brain Modeling.

Zimmer Robotic Shoulder System Cleared

[ Price : $8.95]

FDA clears a Zimmer Biomet 510(k) for the ROSA Shoulder System for robotic-assisted shoulder replacement surgery.

Industry Faults FDA Research on DTC Implied Claims

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Industry stakeholders question the usefulness and design of proposed CDER Office of Prescription Drug Promotion research into impl...

Nearly 1,000 Generic Drugs OKd in 2023

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The CDER Office of Generic Drugs 2023 annual report details the 956 ANDAs approved or tentatively approved last year.

Election Year Will Affect FDA Actions: Attorneys

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Two Hogan Lovells attorneys and two Greenleaf Health executives discuss FDA actions in this election year at a recent J.P. Morgan ...