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Magellan Diagnostics Recalls Blood Lead Tests

[ Price : $8.95]

Magellan Diagnostics recalls its LeadCare II, LeadCare Plus, and LeadCare Ultra blood lead tests due to concerns about false low r...

FDA Staff Update on Data Integrity Issues

[ Price : $8.95]

A panel of FDA staff from CDER and the Office of Regulatory Affairs provide the latest insights into common data integrity inspect...

Condemned Labz Selling Illegal New Drugs: FDA

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FDA warns Condemned Labz that it is marketing misbranded unapproved new drugs.

PhRMA Comments on FDA Safety Reporting Guide

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PhRMA tells FDA it appreciates many of the revisions the agency has made to a draft guidance on sponsor responsibilities for safet...

Priority Review for ViiVs Cabotegravir HIV Preventer

[ Price : $8.95]

FDA grants priority review to ViiVs cabotegravir to prevent acquisition of HIV in certain men.

Affordable Healthcare Pleads Guilty in Adulterated Device Case

[ Price : $8.95]

The Justice Department says Affordable Healthcare Solutions pled guilty to one felony count of receiving adulterated medical devic...

Regeneron Libtayo sBLA for Cervical Cancer

[ Price : $8.95]

FDA accepts for review a Regeneron Pharmaceuticals supplemental BLA for PD-1 inhibitor Libtayo (cemiplimab-rwlc) to treat certain ...

Eisai Rolling BLA for Alzheimers Drug

[ Price : $8.95]

Eisai begins a rolling BLA submission for lecanemab, the companys investigational anti-amyloid beta protofibril antibody for treat...

Pfizer Amends Trial Protocol Due to Adverse Events

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Pfizer submits a clinical trial protocol amendment for a Phase 3 gene therapy trial for fordadistrogene movaparvovec in Duchenne M...

CBERs Marks Takes Over Vaccine Review Office

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CBER director Peter Marks announces he will immediately serve as Office of Vaccines Research and Review (OVRR) acting director, re...