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GSKs Arexvy RSV Vaccine for High-Risk Adults Ages 1849

[ Price : $8.95]

FDA expands the approved use of GSKs Arexvy, a respiratory syncytial virus accine that now includes the in adults aged 18 to 49 wh...

Lilly Warns of Risk in Compounded Tirzepatide/Vitamin B12

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

Two Axinn attorneys explain a new FDA draft guidance on new clinical investigation exclusivity and ways that some NDA and sNDA app...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

[ Price : $8.95]

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FDA Draft Guidance for Medical Devices Intended for Weight Loss

[ Price : $8.95]

FDA posts a draft guidance entitled Medical Devices with Indications Associated with Weight Loss - Premarket Considerations.

AI Has Saved FDA 17,000 Hours: Makary

[ Price : $8.95]

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

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...

Sen. Johnson Probing FDA Rare Disease Denials

[ Price : $8.95]

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