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Breakthrough Status for Cancer Detector

[ Price : $8.95]

FDA grants Geneseeq a breakthrough device designation for its multi-cancer early detection device, CanScan.

Public Citizen Announces Death of Sidney Wolfe

[ Price : $8.95]

Public Citizen mourns the 1/1 death of Health Research Group founder Sidney Wolfe.

3 Observations in Dr. Reddys Lab Inspection

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FDA releases the FDA-483 issued following an inspection at the Dr. Reddys drug testing establishment in Telangana, India.

Update on Drager Neonatal Incubators

[ Price : $8.95]

An FDA safety update says it has determined that new neonatal incubators by Drager (also known as Draeger) do not need to be run f...

Agios Mitapivat Study Meets Endpoint

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Agios Pharmaceuticals reports that the Phase 3 ENERGIZE study of Pyrukynd (mitapivat) in adults with non-transfusion-dependent alp...

FDA 2023 Novel Drug Approvals Up

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FDA says CDER approved 55 new drugs in 2023, almost 50% more than in 2022.

FDA Guidance Best Practices Plan

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FDA asks for comments on a report on agency best practices for guidance documents.

Commerce Committee Probes FDA Internal Disputes

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The U.S. House Energy and Commerce Committees Republican leadership opens an investigation into FDAs handling of internal scientif...

Laurus Synthesis FDA-483

[ Price : $8.95]

FDA releases the form FDA-483 issued to Indias Laurus Synthesis with five inspection observations.

Torrent Pharmaceuticals FDA-483

[ Price : $8.95]

FDA releases the form FDA-483 issued following an inspection at Indias Torrent Pharmaceuticals drug manufacturing facility.