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Agency Has Evolved in the Last 10 Years: Verdun

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CBERs Nicole Verdun tells a Friends of Cancer Research meeting on next-generation therapies that FDA has evolved in the last decad...

Makary Says Vaccine Framework Coming Soon

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FDA commissioner Marty Makary says the agency is planning to release in the coming days a vaccine development framework to help wi...

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

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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...

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...