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Senate Letter Presses HHS on Foreign Generic Drugs

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A Senate Committee demands answers from HHS on what they describe as serious national security and public health risks tied to Ame...

BridgeBio Plans NDA for Muscular Dystrophy Therapy

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BridgeBio reports positive Phase 3 data for BBP-418 in limb-girdle muscular dystrophy patients as it plans an NDA filing in second...

Guide on Device Quality Management Submission Info

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FDA releases a draft guidance outlining recommendations for medical device manufacturers on the type of Quality Management System ...

Hetero Labs India Warehouse Cited After Inspection

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FDA posts a six-item Form FDA-483 after inspecting Hetero Labs Vishakapatnam, India, warehouse last month.

FDA Expands Mercks Winrevair Label

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FDA approves an expanded indication for Mercks pulmonary arterial hypertension therapy Winrevair (sotatercept-csrk), clearing the ...

YorLabs Novel Intracardiac Imaging System Cleared

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FDA clears a YorLabs 510(k) for its new intracardiac imaging system that the company says could reshape workflows in catheterizati...

Inhibrx Posts Positive Phase 3 Results for Ozekibart

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Inhibrx Biosciences reports favorable data for treating chondrosarcoma with its antibody therapy ozekibart (INBRX-109).

Sumitomo Pharma Gets FDA-483 After Inspection

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FDA posts a two-item Form FDA-483 from an August inspection of Sumitomo Pharmas Suzuka, Japan, manufacturing facility.

FDA Payroll Glitch Delays Pay for Some Exempt Staff

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An FDA payroll system error causes a paycheck delay for some FDA employees who are designated to continue working during the ongoi...

Bayer Dual-Neurokinin Menopause Drug Approved

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FDA approves Bayers Lynkuet (elinzanetant) to treat moderate to severe vasomotor symptoms associated with menopause.