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FDA Breakthrough Status for Mercks Keytruda

[ Price : $8.95]

FDA grants Merck a breakthrough therapy designation for Keytruda (pembrolizumab), an anti-PD-1 therapy for treating patients with ...

Vertex Pharma Receives Subpoena Over GLPs

[ Price : $8.95]

Vertex Pharmaceuticals says it received a subpoena from the U.S. Department of Justice in the third quarter related to its Good La...

OIG Aims to Examine Post-marketing Requirements

[ Price : $8.95]

HHS Office of Inspector General plans to examine how FDA requires NDA holders to conduct postmarketing studies and the agencys ove...

FDA Grants Expedited Access Designation for MyoRegulator

[ Price : $8.95]

FDA grants PathMaker Neurosystems an Expedited Access Pathway designation for its MyoRegulator PM-2200 system for use in treating ...

Guidance on Dispenser Product Tracing Requirements

[ Price : $8.95]

Federal Register Notice: FDA issues a revised guidance: DSCSA Implementation: Product Tracing Requirements for Dispensers Complia...

Guidance on Progesterone Gel BE Studies

[ Price : $8.95]

Federal Register Notice: FDA releases a document for industry: Draft Guidance on Progesterone to provide recommendations on bioequ...

Guidance on Electromagnetic Compatibility of Devices

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance: Information to Support a Claim of Electromagnetic Compatibility (EMC) of E...

Gastrointestinal Assay into Class 2

[ Price : $8.95]

Federal Register Final order: FDA classifies a gastrointestinal assay into Class 2.

Acadia Pharma Parkinsons Drug Gains Priority Review

[ Price : $8.95]

FDA accepts for priority review an Acadia Pharmaceuticals NDA for Nuplazid (pimavanserin) for treating psychosis associated with P...

Tryton Medical PMA for Side Branch Stent

[ Price : $8.95]

Tryton Medical files the final module of its PMA for the Tryton Side Branch Stent, indicated for treating bifurcated lesions in pa...