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FDA releases a draft guidance outlining recommendations for medical device manufacturers on the type of Quality Management System ...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

Dr. Reddys Hit with 7-Item FDA-483

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FDA posts a seven-item Form FDA-483 after inspecting Dr. Reddys Mirfield, West Yorkshire, UK, active pharmaceutical ingredient man...

Intellia Pauses Gene Therapy Phase 3 Trials

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Intellia Therapeutics pauses two Phase 3 trials of nex-z, a CRISPR-based therapy for transthyretin amyloidosis with cardiomyopathy...

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...

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).