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FDA Warns MAST Biosurgery Over Manufacturing Violations

[ Price : $8.95]

FDA issues MAST Biosurgery a Warning Letter after an August inspection cited serious manufacturing quality and safety reporting vi...

Drug Companies Using AI to Speed Submissions

[ Price : $8.95]

Reuters reports that several drug companies say they are using artificial intelligence tools to speed up some of the time-intensiv...

CGMP Issues at Malaysias Fulijaya Manufacturing

[ Price : $8.95]

FDA warns Malaysias Fulijaya Manufacturing about CGMP violations in its production of finished drugs.

Using AI in Tumor Assessment

[ Price : $8.95]

A Friends of Cancer Research white paper explores the emerging role of AI-enabled tumor assessment tools and the framework needed ...

Roche Reports Positive Phase 2 Data for Obesity Drug

[ Price : $8.95]

Roche says its experimental dual GLP-1/GIP receptor agonist CT-388 delivered substantial and statistically significant weight loss...

Former CytoDyn CEO Sentenced to Prison

[ Price : $8.95]

A federal judge sentences former CytoDyn chief executive Nader Pourhassan to 30 months in prison for misleading investors about th...

FDA Cites Pine Pharma Over Sterility, Quality Control

[ Price : $8.95]

FDA cites Pine Pharmaceuticals for multiple quality and sterility violations following a 10-day inspection of the companys drug ou...

Plausible Mechanism Drug Pathway Raises Process Concerns

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A Health Affairs analysis on FDAs new pathway allowing drug approvals based on a plausible mechanism of action warns that the appr...

Sarepta Reports Positive Data on Duchenne Gene Therapy

[ Price : $8.95]

Sarepta Therapeutics announces that its gene therapy Elevidys significantly slowed disease progression over three years in ambulat...

Advocacy Push Precedes FDA Meeting on Stalled Gene Therapy

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AMT-130 is a gene therapy designed to lower levels of the mutant huntingtin protein believed to drive Huntingtons disease progress...