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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

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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...

Indian API Maker Hit with Warning Letter

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FDA sends Indian active pharmaceutical ingredient manufacturer Mentha & Allied Products a Warning Letter that cites the firm for s...

FDA Wants Public Deregulation Input

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FDA and HHS ask public stakeholders for their ideas on regulations that should be eliminated.

CGMP Violations at Excelvision Fareva

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FDA warns Frances Excelvision Fareva about CGMP violations in its production of finished drugs.

FDA Moves to Ban Pediatric Ingestible Fluoride Drugs

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FDA plans to remove from the market concentrated ingestible fluoride prescription drug products for children, citing safety concer...

Assertio Pays $3.6 Million Over Improper Marketing

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Assertio Therapeutics agrees to pay $3.6 million to resolve claims that it violated the False Claims Act by causing the submission...

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.