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FDA Viral Mutation Impact on Tests Web Page

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FDA launches a new Web page for clinical lab staff and healthcare providers on the impact of viral mutations on Covid-19 tests.

Panel to Review Endovascular Graft Device Endoleaks

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CDRH says it will hold a two-day meeting of its Medical Devices Advisory Committees Circulatory System Devices Panel to review inf...

Mirum NDA for Maralixibat Accepted for Review

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FDA accepts for priority review a Mirum Pharmaceuticals NDA for maralixibat, an oral apical sodium dependent bile acid transporter...

Celgene BLA for Abecma OKd for Multiple Myeloma

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FDA approves a Celgene BLA for Abecma (idecabtagene vicleucel), a cell-based gene therapy for treating certain adult patients with...

Astellas Pharma Gains Myrbetriq Pediatric Use

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FDA approves an Astellas Pharma NDA for Myrbetriq (mirabegron extended-release tablets) for treating neurogenic detrusor overactiv...

FDA De Novo Authorization for MS Gait Deficit

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FDA grants a de novo marketing authorization for Helius Medicals Portable Neuromodulation Stimulator, indicated for use as a short...

FDA Denies Keytruda for Triple-negative Breast Cancer

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FDA sends Merck a complete response letter on a supplemental BLA for Keytruda, the companys anti-PD-1 therapy for treating certain...

FDA Dismisses Study as Support for Makena Approval

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CDER says a recently published meta-analysis of progestogen use to reduce pre-term birth risk is not persuasive and will not chang...

OTC Drug User Fee Rates Announced

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Federal Register notice: FDA announces the user fee rates under the Over-the-Counter Monograph Drug User Fee Program for fiscal ye...

Panel to Review ChemoCentryx Vasculitis NDA

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Federal Register notice: FDA announces a 5/6 Arthritis Advisory Committee meeting. Pto discuss a ChemoCentryx NDA for avacopan ora...