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FDA Warning Letters Surge in FY2025, Report Finds

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A regulatory consulting firm's report finds that FDA sharply increased enforcement activity against drugmakers and distributors in...

Enforcement, Advertising Oversight Shape Regulatory Landscape: Legal Update

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A legal update from ArentFox highlight several emerging regulatory and enforcement developments at FDA thatare expected to have si...

Uncertainty for Gene Therapy, Rare Disease & Vaccines in Prasad Exit Wake

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CBER director Vinay Prasads departure at the end of next month raises questions across the biotechnology sector about how the agen...

Concerns Mount Over Fast Drug Review Voucher Program

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Former FDA official Grail Sipes says questions are emerging about the long-term impact of the Commissioners National Priority Vouc...

Insulet Device Correction for Certain Omnipod 5 Insulin Pods

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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

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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

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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

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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.