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BioMarin Asked to Submit New Data on Gene Therapy

[ Price : $8.95]

BioMarin Pharmaceutical says FDA is requesting results from an upcoming three-year data analysis from the ongoing Phase 3 GENEr8-1...

Califf Comes Down With Covid-19

[ Price : $8.95]

FDA commissioner Robert Califf tests positive for Covid-19 while traveling over the weekend on agency business.

Guide on Bioanalytical Method Validation

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FDA posts a final guidance entitled M10 Bioanalytical Method Validation and Study Sample Analysis.

Lilly Covid Therapy has Reduced Variant Activity: FDA

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FDA updates the Health Care Provider Fact Sheet for Eli Lillys Covid-19 antibody therapy bebtelovimab to highlight expected reduce...

Guide on Studying Multiple Cell/Gene Therapies

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FDA releases a final guidance entitled Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical...

HIV Viral Load Test Down Classified to Class 2

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Federal Register notice: FDA issues a final order to reclassify human immunodeficiency virus viral load monitoring tests from Clas...

FDA Revokes 2 Cleveland Clinic Covid EUAs

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Federal Register notice: FDA revokes the Emergency Use Authorizations issued to the Cleveland Clinic for two Covid-19 tests.

Apellis Pharma NDA Review Extended on New Data

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FDA extends by three months its review of an Apellis Pharmaceuticals NDA for intravitreal pegcetacoplan based on new data submitte...

New MDIC Framework on Device Trials

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The Medical Device Innovation Consortium releases a new framework that outlines a systematic approach for patient-focused clinical...

21 State AGs Urge FDA OK of OTC Birth Control

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Twenty-one state attorneys general urge FDA to approve over-the-counter birth control pills.