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Insulet Device Correction for Certain Omnipod 5 Insulin Pods

[ Price : $8.95]

Insulet initiates a Class 1 device correction for certain lots of its Omnipod 5 Automated Insulin Delivery System pods after ident...

Novartis Cosentyx OKd for Adolescents With Hidradenitis Suppurativa

[ Price : $8.95]

FDA approves Novartis Cosentyx (secukinumab) for treating adolescents aged 12 and older with moderate to severe Hidradenitis Suppu...

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

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Two Axinn attorneys explain a new FDA draft guidance on new clinical investigation exclusivity and ways that some NDA and sNDA app...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FDA Draft Guidance for Medical Devices Intended for Weight Loss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FDA posts a draft guidance entitled Medical Devices with Indications Associated with Weight Loss - Premarket Considerations.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...