Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

Menu

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
My View
Tags:
BioPharmaceutical United States Advisory Committees

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

This article was originally published in The Pink Sheet Daily

  • News

Executive Summary

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

You may also be interested in...



Rare Disease Cures Accelerator Expected To Drive Lots Of Development – Eventually

Sarepta Eyes Patient Outcomes To Boost Exondys 51's European Review

EMA and payers want to know more about daily life improvements from US FDA-approved Duchenne muscular dystrophy treatment.

Sarepta's Eteplirsen Is Centerpiece Of Senate Hearing On Expanded Access

Witnesses call for political pressure on FDA to approve the Duchenne drug; patients and advocates also urge general approval reciprocity with Europe and incentives for pediatric trials; agency was not invited to testify.

Table

View full table

Related Content

Pink Sheet
Pink Sheet

Topics

Related Companies

Tags:
BioPharmaceutical United States Advisory Committees
Latest News

Keeping Track: Tumor-Agnostic Approval For Novartis; Submissions From Krystal, Menarini, And Astellas

RSV Vaccine May Be On Market In 2023, CDC’s ACIP Anticipates

Drugs From Sponsors ‘Located in Russia,’ Would Be Barred From US FDA Review By House Funding Bill

US FDA Would Allow Separation Alternatives In Manufacture Of Low-Risk Beta-Lactams

UsernamePublicRestriction

Register

PS079338

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By