Generics BulletinHBW InsightIn VivoMedtech InsightPink SheetScrip

Generics Bulletin

Medtech Insight

Exondys Revisited? Translarna Brings Efficacy Woes Into US Panel Review

Sep 27 2017

• By Sue Sutter

FDA entrance sign 2016

Related Content

Accelerated Approval After Eteplirsen: A Lowered Bar Or A Unique Event?

Sep 21 2016

Sarepta Complained To Woodcock About Exondys 51 Review Early And Often

Sep 07 2017

Once More Unto The Breach: PTC's Duchenne Drug Translarna Gets Advisory Cmte.

Aug 22 2017

Woodcock's 'Bias' In Sarepta Case Made Jenkins Worry About Future Drug Reviews

Aug 01 2017

‘File Over Protest’ At US FDA: PTC To Pursue Rarely-Used Pathway For DMD Drug

Jan 10 2017

Related Companies

PTC Therapeutics, Inc.

Sarepta Therapeutics, Inc.

BioMarin Pharmaceutical Inc.

Additional Topics

United States Advisory Committees Drug Review Regulation BioPharmaceutical Neurology

More from US FDA Performance Tracker

More from Regulatory Trackers

Twitter feed RSS feed RSS feed

About Us

Meet the TeamOpens in new window
RSS FeedOpens in new window

Contact Us

Customer Service
SubscribeOpens in new window
AdvertisingOpens in new window
Feedback

Terms and ConditionsOpens in new window

Privacy PolicyOpens in new window

Copyright © 2025 Pharma Intelligence UK Limited (Citeline), a Norstella company Pharma Intelligence UK Limited is a company registered in England and Wales with company number 13787459 whose registered.