Generics BulletinHBW InsightIn VivoMedtech InsightPink SheetScrip

Generics Bulletin

Medtech Insight

Refining A Controversial Endpoint: Sarepta Banking On Dystrophin Levels For Golodirsen Approval In DMD

Mar 13 2018

• By Michael Cipriano

Related Content

Keeping Track: Apadaz Approved Without Abuse-Deterrent Label, FDA Denies Translarna Appeal, And Some Priority Reviews

Feb 25 2018

PTC’s Ataluren and Accelerated Approval: Is Eteplirsen A Precedent After All?

Mar 01 2018

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

Sep 21 2016

Sarepta's Eteplirsen Approved After Contentious Internal FDA Debate

Sep 20 2016

PTC To Appeal Translarna's Complete Response Letter From US FDA

Oct 25 2017

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

Jan 10 2017

No More Sarepta-Like Development, FDA Officials Say

Oct 20 2016

Related Companies

Sarepta Therapeutics, Inc.

PTC Therapeutics, Inc.

Additional Topics

United States Drug Approval Standards Drug Review Review Pathway Clinical Trials Regulation Neurology BioPharmaceutical

More from Approval Standards

More from Pathways & Standards

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.