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sNDA for Lynparza Accepted for Review

[ Price : $8.95]

FDA accepts for priority review an AstraZeneca supplemental NDA for Lynparza (olaparib) in combination with bevacizumab for the ma...

Meeting on Asbestos in Talc and Cosmetic Products

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Federal Register notice: FDA announces a 2/4 public meeting entitled Testing Methods for Asbestos in Talc and Cosmetic Products Co...

Meissa Gains Fast Track for RSV Infection Vaccine

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FDA grants Meissa Vaccines a fast track designation for MV-012-968, a vaccine for protection against respiratory syncytial virus i...

Reflow Medical Breakthrough for Stent System

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FDA grants Reflow Medical a breakthrough device designation for the Temporary Spur Stent System, a novel retrievable stent technol...

MicroVention Flow Diverter OKd for Brain Aneurysm

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FDA approves a MicroVention PMA for the FRED (Flow Re-Direction Endoluminal Device) device for treating brain aneurysms.

Petition Seeks to Stop FDA Enforcement on PGx Info

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The Coalition to Preserve Access to Pharmacogenomics Information petitions FDA urging it to stop enforcement actions against genet...

Alnylam Rolling NDA for Lumasiran

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Alnylam Pharmaceuticals begins a rolling submission of its NDA for lumasiran, an investigational RNAi therapeutic targeting glycol...

Guide on PTA and Specialty Catheter 510(k)s

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FDA releases a draft guidance on Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters Premarket Notific...

SCA Pharma 6-item Form 483 After Inspection

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FDA issues SCA Pharmaceuticals a six-observation Form 483 after a November inspection cited GMP issues at the drug outsourcing fac...

Bayer Removes from Market 99% of Essure Devices

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A year after Bayer stopped selling and distributing its Essure implantable contraceptive device, CDRH director Jeff Shuren says Ba...