1. Pink Sheet
  2. >>Geography
  3. >>North America

NASH Drugs Soon May Have A Registrational Pathway, Finally

Numerous companies vie to become first to market with a therapy for the unmet medical need, which can lead to fibrosis, cirrhosis and need for a liver transplant. FDA may allow surrogate endpoints in pivotal trials to speed up approval of initial NASH therapies.

Due to the lack of clear endpoints, sponsors have been waiting to advance non-alcoholic steatohepatitis (NASH) candidates into pivotal trials. But with an agreement with FDA on the horizon, the leading candidate should have a Phase III protocol in place in the next few months.

NASH is seen as a coming epidemic of liver disease, presenting a host of serious issues and co-morbidities arising from...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

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