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FDA Expands Mercks Winrevair Label

[ Price : $8.95]

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

YorLabs Novel Intracardiac Imaging System Cleared

[ Price : $8.95]

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

Sydnexis Hit with FDA Rejection for Myopia Drug

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FDA sends Sydnexis a complete response letter for SYD-101, a low-dose atropine eye-drop candidate intended to slow disease progres...

FDA Breakthrough for NRG1+ Cholangiocarcinoma Drug

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FDA grants Partner Therapeutics a breakthrough therapy designation for zenocutuzumab-zbco and its use in treating cholangiocarcino...

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.

Tango Therapeutics Encouraging Cancer Drug Data

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Tango Therapeutics reports that new data from its ongoing Phase 1-2 study of vopimetostat (TNG462) showed early signs of efficacy ...

FDA Blocking Drug Info Consumers Need: Report

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A ProPublica investigative report faults FDA for blocking information about foreign-made generic drugs that could help patients, d...