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Group Backs Circulating Tumor DNA as Early Endpoint

[ Price : $8.95]

Friends of Cancer Research publishes two scientific articles it says demonstrate the value of circulating tumor DNA as an early en...

R3 Selling Unapproved Drugs, Biologics, FDA Says

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FDA warns Scottsdale, AZ-based R3 Medical Companies that its Bello Bio and Regen Suppliers units are selling unapproved drugs that...

FDA Approves First Drug for Warm Autoimmune Hemolytic Anemia

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FDA approves a Janssen Biotech BLA for Imaavy (nipocalimab-aahu) injection for warm autoimmune hemolytic anemia in adult and pedia...

Create Unified Reference-Anchored Framework for Follow-Ons

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Washington State University pharmacy professor Sarfaraz Niazi asks FDA to create an equivalence framework for follow-on human drug...

Webinar on FDAs Bayesian Draft Guidance

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FDA announces a 10/14 Webinar on its recent draft guidance on Use of Bayesian Methodology in Clinical Trials of Drugs and Biologic...

Wearable Device Monitors Ketone Levels and Blood Sugar

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FDA grants Abbott Diabetes Care a de novo authorization for the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System ...

Jemperli sBLA for Rectal Cancer Accepted for Priority Review

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FDA accepts for priority review a GSK supplemental BLA for Jemperli (dostarlimab) for certain patients with previously untreated S...

Comments on Expedited IND Pilot

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Three stakeholders provide their responses to an FDA Request for Information on the Operation TrialBlazer Expedited IND Pilot Proj...

Device, Drug Recalls Down, Units Up

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The Sedgwick Recall Index shows that in the first half of 2026, medical device and drug recalls fell, but the number of recalled u...

FDA 3-Month Review Extension on Capricor Gene Therapy

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FDA extends by three months its review of a Capricor Therapeutics BLA for Deramiocel, an investigational cell therapy for Duchenne...