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FDA Panel Backs Trivalent Influenza Vaccine for 2027 Season

[ Price : $8.95]

FDAs Vaccines and Related Biological Products Advisory Committee votes to recommend that seasonal influenza vaccines for the 20262...

Lilly Warns of Risk in Compounded Tirzepatide/Vitamin B12

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Eli Lilly issues a public warning that its testing found that compounded tirzepatide with vitamin B12 can produce an unknown impur...

BridgeBio Data on BBP-418 in Limb-Girdle Muscular Dystrophy

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BridgeBio says its investigational therapy BBP-418 showed consistent clinical benefit and a favorable safety profile in an interim...

FDA OKs J&Js Tecnis PureSee Lens for Cataract Surgery

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FDA approves Johnson & Johnsons Tecnis PureSee Intraocular Lens, a new extended depth-of-focus lens for use in cataract surgery.

Attorneys Discuss New FDA Draft NCI Guidance

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Two Axinn attorneys explain a new FDA draft guidance on new clinical investigation exclusivity and ways that some NDA and sNDA app...

Continue Modernizing Foreign Inspections: Study

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Academic researchers call on FDA to continue to modernize its foreign drug inspection program and overcome differences in inspecti...

FDA Draft Guidance for Medical Devices Intended for Weight Loss

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FDA posts a draft guidance entitled Medical Devices with Indications Associated with Weight Loss - Premarket Considerations.

AI Has Saved FDA 17,000 Hours: Makary

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FDA commissioner Marty Makary explains how the agency is using AI to modernize tedious tasks performed by humans to make drug revi...

Sen. Johnson Probing FDA Rare Disease Denials

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Senator Ron Johnson (R-WI) launches a congressional investigation into FDAs recent decisions to reject or delay treatments for rar...

FDA Opens New, Searchable Adverse Event Platform

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FDA launches its new Adverse Event Monitoring System to ultimately house all adverse events reported on FDA-regulated products on ...