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Clene Plans ALS Drug Filing After Input on Accelerated Path

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Clene says it plans to submit an NDA in the third quarter for its experimental amyotrophic lateral sclerosis therapy.

High Court Pauses Limits on Mifepristone

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The U.S. Supreme Court issues a temporary pause on a 5/1 lower court ruling that would have curtailed access to the abortion pill ...

Scrutiny of Gene Therapy Evidence Intensifies After Recent Setbacks

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An opinion article notes that recent FDA regulatory decisions are leading to a sharper focus on the evidentiary standards underpin...

Alnylam Pharmas Web Promo is Misleading: FDA

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FDA sends an untitled letter to Alnylam Pharmaceuticals, citing misleading promotional claims on a consumer-facing Web site for it...

Allergans Ireland Plant Hit With 483 After Inspection

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FDA cites multiple manufacturing and quality control deficiencies at a facility operated by Allergan Pharmaceuticals in Ireland fo...

Town Hall on BLA Submissions for Cell and Gene Therapies

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FDA plans a 6/4 town hall meeting aimed at guiding drug developers through the process of preparing BLAs for cell and gene therapy...

PhRMA Urges Changes to FDAs Plausible Mechanism Guidance

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PhRMA urges FDA to broaden and clarify its draft guidance on individualized therapies, warning that overly narrow definitions and ...

Expanded Access Program for Promising Pancreatic Cancer Drug

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FDA authorizes an expanded access program for an experimental pancreatic cancer therapy from Revolution Medicines, allowing certai...

Veppanu Approved for Advanced Breast Cancer

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FDA has approved Arvinas Operations Veppanu (vepdegestrant) for treating certain patients with advanced breast cancer, marking the...

Eugia Pharma Specialties FDA-483 Out

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FDA releases the form FDA-483 with three observations from an inspection at Indias Eugia Pharma Specialties Limited.