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Emigality Misses Superiority in Clinical Trial

[ Price : $8.95]

Eli Lilly says a head-to-head clinical trial comparing its migraine drug Emgality (galcanezumab-gnlm) to Pfizers Nurtec ODT (Rimeg...

FDA OKs Premia Spine Fusion Alternative

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FDA approves Premia Spines TOPS System as an alternative to spinal fusion for treating certain patients with degenerative spondylo...

CVM Guide on Soluble Powder Bioequivalence

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FDA publishes a CVM guidance entitled #171 Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Me...

Columvi Accelerated Approval for Lymphoma

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FDA grants Genentech accelerated approval for its BLA for Columvi (glofitamab-gxbm) and its use in treating adult patients with re...

Positive Data Added to BMS Heart Drug Label

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FDA approves a Bristol Myers Squibb supplemental NDA to add positive data from its Phase 3 VALOR-HCM study to the U.S. prescribing...

FDA Backs Monovalent XBB.1.5 Covid Vaccine

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FDA advises manufacturers that they should develop vaccines with a monovalent XBB.1.5 composition, according to a notice posted on...

Reps. Introduce Drug Labeling Bill

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Reps. Schiff and Kuster introduce legislation to direct FDA to establish a process to allow generic drug manufacturers to update d...

Panel Backs Monovalent XBB Variant Covid Vaccine

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FDAs Vaccines and Related Biological Products Advisory Committee votes 21 to 0 that the Covid-19 vaccination program for the 2023-...

AI/ML Challenges in Precision Medicine: FDA Paper

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FDA researchers discuss ways to improve the use of AI/ML in precision medicine.

Corvus Wants FDA Meeting on CPI-818 Trial

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Corvus Pharmaceuticals seeks a 3rd quarter meeting with FDA to discuss a Phase 3 trial for its investigational cancer drug CPI-818...