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CGMP Violations at Chinas Shantou S.E.Z. Baojie

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FDA warns Chinas Shantou S.E.Z. Baojie Industry about CGMP violations in its production of finished drugs, some of which may be re...

FDA Doubts May Move Trials Overseas: Report

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Biotech executives, investors, and consultants say some companies are moving early clinical trials overseas due to fears of instab...

FDA OKs First Oral Therapy for Rare Adrenal Tumors

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FDA approves a Merck NDA for Welireg (belzutifan), an oral drug for treating adults and pediatric patients aged 12 and older with ...

AbbVies Emrelis Approved for Lung Cancer

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FDA gives AbbVie accelerated approval for its Emrelis (telisotuzumab vedotin-tllv) for treating certain adult patients with locall...

BrightHeart AI Fetal Heart Ultrasound Checker Cleared

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FDA clears a BrightHeart 510(k) for the B-Right Views, an artificial intelligence-powered tool that automatically detects the stan...

GAO Pushes Its FDA Recommendations to Kennedy

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The Government Accountability Office tells HHS secretary Robert F. Kennedy, Jr., about priority recommendations it has made in the...

Taizhou Jingshang Cosmetics CGMP Issues

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FDA warns Chinas Taizhou Jingshang Cosmetics Technology Co. about CGMP violations in its production of finished drugs.

FDA Hits Mayne Nextstellis Professional Presentation

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The CDER Office of Prescription Drug Promotion hits Mayne Pharma over a professional presentation on Nextstellis that it says make...

GSK, iTeos Therapeutics Scrap Lung Cancer Candidate

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GSK and iTeos Therapeutics decide to stop the development of belrestotug, an anti-TIGIT monoclonal antibody for treating certain n...

FDA Needs GLP-1 Long-Range Plan: Kessler

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Former FDA commissioner David Kessler, who is taking one of the new weight loss drugs, calls on FDA to require data to help people...