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DOGE-Targeted FDA Lab to Remain Open

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The Trump Administration reverses an Elon Musk decision to terminate the lease of a 52,000 square foot major FDA laboratory in St....

Orphan Drug Designation for Farons Bexmarilimab

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FDA grants orphan drug designation to Farons bexmarilimab to treat myelodysplastic syndrome.

Roche Files sBLA for Gazyva in Lupus

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

Indian-Made Generics Have Higher Risk: Study

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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

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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

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Two stakeholders suggest changes to an FDA draft guidance on protocol deviations in clinical studies.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