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Results of Phase III HERCULES, GEMINI 1 and 2 Trials Lead to FDA Priority Review for Tolebrutinib for Non-Relapsing Secondary Progressive MS

March 25th 2025

FDA grants Priority Review status to Sanofi's tolebrutinib for the treatment of non-relapsing secondary progressive multiple sclerosis based on positive findings from multiple Phase III trials.

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Clinical Research, DEI Initiatives Caught in Political Headwinds Amidst Funding Freeze

February 13th 2025

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Analysis of Clinical Trial Characteristics Show Typical Drug Development Costs Are Lower Than Expected, Skewed by High-Cost Outliers

January 8th 2025

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Revolutionizing Oncology: Insights on the FDA’s Project Optimus and Dose Optimization

September 20th 2024

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FDA Fast Tracks Johnson & Johnson’s Nipocalimab for Fetal Neonatal Alloimmune Thrombocytopenia

March 27th 2024

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Patient Demands vs. Product Development

Jill Wechsler, ACT's Washington Correspondent
September 1st 2001

As the public clamors for early access to promising new drugs, sponsors worry about the consequences of experimental therapy conducted outside of controlled trials.

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Ethics, Kids, and Sex

Jill Wechsler, ACT's Washington Correspondent
August 1st 2001

As the debate on clinical research policy continues, FDA is setting standards for pediatric studies and encouraging more sex-specific analysis of clinical data.

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