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Sarepta's Additional Data Doesn't Sway FDA On Eteplirsen

 
• By Derrick Gingery

Agency reviewers raise more concerns about efficacy of proposed Duchenne muscular dystrophy treatment despite new information.

It does not appear additional data and time for review have improved the prospects for Sarepta Therapeutics Inc.'s proposed Duchenne muscular dystrophy treatment eteplirsen.

The product had already appeared to face long odds for approval when FDA released its initial briefing documents for eteplirsen's...

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More from United States

Podium Policy Returns To US FDA, Or Is It Podcast Policy?

 
• By Michael McCaughan

US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.

US FDA’s Elsa AI Platform Is Not Guiding Regulatory Decisions, Official Says

 
• By Cathy Kelly

Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.

Branch Chief Vijay Kumar Named Acting Head Of US FDA’s Cell, Gene Therapy Office

 
• By Derrick Gingery

Kumar takes over as acting director of the Center for Biologics Evaluation and Research’s Office of Therapeutic Products days after director Nicole Verdun was ousted.

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.

More from North America