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Roche Files sBLA for Gazyva in Lupus

[ Price : $8.95]

FDA accepts for review a supplemental BLA for Gazyva (obinutuzumab) for treating lupus nephritis.

Indian-Made Generics Have Higher Risk: Study

[ Price : $8.95]

An Ohio State University business school study finds that generic drugs made in India are 54% more likely to be associated with se...

FDA Clinical Hold on BioNTech Malaria Vaccine

[ Price : $8.95]

FDA places a clinical hold on BioNTechs Phase 1/2a dose escalation clinical trial evaluating an investigational RNA-based vaccine ...

ARS Pharma Gets Expanded OK for Neffy

[ Price : $8.95]

FDA approves an ARS Pharmaceuticals supplemental NDA for Neffy (epinephrine nasal spray 1mg) for treating Type I allergic reaction...

CGMP Violations at Granules India Limited

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FDA warns Indias Granules India Limited about CGMP violations in its production of finished drugs.

Comments on Protocol Deviations Guidance

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Two stakeholders suggest changes to an FDA draft guidance on protocol deviations in clinical studies.

Makary To Divest Extensive Holdings: Ethics Report

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The ethics form submitted to HHS by FDA commissioner nominee Martin Makary says he will resign his position at Johns Hopkins Unive...

Chem-Tech Inspection Violations

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FDA warns Pleasantville, IA-based Chem-Tech about CGMP violations in its manufacturing of finished drugs.

Capricor BLA for Duchenne-related Cardiomyopathy

[ Price : $8.95]

FDA accepts for priority review a Capricor Therapeutics BLA for deramiocel, a cell therapy for treating patients diagnosed with Du...

Celltrions Prolia and Xgeva Biosimilars Approved

[ Price : $8.95]

FDA approves a Celltrion BLA for Stoboclo (denosumab-bmwo), a biosimilar to Amgens Prolia, and Osenvelt (denosumab-bmwo), a biosim...