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Webinar on FDAs Bayesian Draft Guidance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FDA announces a 10/14 Webinar on its recent draft guidance on Use of Bayesian Methodology in Clinical Trials of Drugs and Biologic...

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...

Early Alert on CooperSurgical Neonatal CPAP Ventilator

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FDA issues an early alert about a potentially high-risk problem involving certain CooperSurgical INCA neonatal and infant nasal co...

Roche/Lilly Alzheimers Test Cleared

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FDA clears Roche/Eli Lillys Elecsys Phospho-Tau (217P) Plasma (pTau217) blood test as a single blood-based option to aid in identi...