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Device, Drug Recalls Down, Units Up

[ Price : $8.95]

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

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 ...

Group Backs Circulating Tumor DNA as Early Endpoint

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Webinar on FDAs Bayesian Draft Guidance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FDA announces a 10/14 Webinar on its recent draft guidance on Use of Bayesian Methodology in Clinical Trials of Drugs and Biologic...

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...

Study Finds Severe Liver Injury in Small Number of Avacopan Patients

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As Amgen continues its bid to prevent the withdrawal of Tavneos (avacopan) in the U.S., a new study finds that while liver enzyme ...

Clinical Hold on Regenxbio Hunter Syndrome Gene Therapy

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FDA places a clinical hold on Regenxbio's investigational gene therapy RGX-121 after asymptomatic spine MRI findings were identifi...