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J&J Wins Monotherapy Use for Spravato

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FDA approves a Johnson & Johnson supplemental NDA for Spravato (esketamine) nasal spray for monotherapy use in treating major depr...

Biomarker Bioanalytical Method Validation

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FDA publishes a guidance on a bioanalytical method to validate biomarkers in drug and biological product applications.

7 Observations on SCA Pharmaceuticals FDA-483

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FDA releases the form FDA-483 with seven observations from an inspection at the Windsor, CT-based SCA Pharmaceuticals outsourcing ...

FDA, Other Agencies Ordered Back in Office

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President Donald Trump orders all government departments and agencies like FDA to end work-from-home arrangements and head back to...

Replimune BLA for Melanoma Gets Priority Review

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FDA accepts for priority review a Replimune Group BLA for RP1 (vusolimogene oderparepvec) in combination with nivolumab for patien...

Amylyx Clinical Hold Lifted on ALS Drug

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FDA lifts a clinical hold on an Amylyx Pharmaceuticals Phase 1 clinical trial of AMX0114, an investigational antisense oligonucleo...

Animal Drug Regs Amended for Recent Approvals

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Federal Register notice: FDA amends its regulations to reflect recent application-related actions for new animal drug applications...

Amgens Lumakras/Vectibix OKd in Colon Cancer

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FDA approves Amgens Lumakras (sotorasib) for use with its Vectibix (panitumumab) for adult patients with KRAS G12C-mutated metasta...

CDER Commits to 11 Drug Quality Guides in 2025

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CDER posts its latest guidance agenda that shows it is committing to issuing 11 drug quality guidance documents in 2025.