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AbbVies Emrelis Approved for Lung Cancer

[ Price : $8.95]

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

[ Price : $8.95]

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...

Malaysias BioAsia Worldwide CGMP Issues

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FDA warns Malaysias BioAsia Worldwide about CGMP violations in its production of finished drugs, some of which may be regulated as...

Cytokinetics Reports Exercise Data on Heart Drug

[ Price : $8.95]

Cytokinetics reports topline results from its Phase 3 MAPLE-HCM clinical trial showing that aficamten significantly improved exerc...

Hunter Syndrome Gene Therapy Accepted for Review

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FDA accepts for priority review a Regenxbio BLA seeking accelerated approval for gene therapy RGX-121 (clemidsogene lanparvovec) f...

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...