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Drisapersen Advisory Committee Is Rough Welcome To FDA For Patient Groups

 
• By Derrick Gingery

Advocates counter FDA’s problems with Duchenne muscular dystrophy treatment's trial data using real-life experience.

Spirits were not necessarily high among Duchenne muscular dystrophy patients and advocates heading into FDA’s advisory committee meeting on BioMarin Pharmaceutical Inc.’s drisapersen.

After reviewing FDA’s largely negative meeting briefing document, many of the attendees at the Nov. 24 Peripheral and Central Nervous...

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Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

US FDA Could Miss User Fee Spending Triggers With House FY 2026 Funding

 
• By Sarah Karlin-Smith and Derrick Gingery

FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.

PCMA, CVS, Cigna File Lawsuits Over ‘Dangerous’ Arkansas PBM Law

 
• By Tim Casey

The suits are an early test of the Arkansas law banning company ownership of PBMs and pharmacies in the state, as other states consider similar legislation.