Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Sarepta Scores Another Remarkable Approval With Vyondys 53 For Duchenne

Executive Summary

Formal dispute resolution was key element in four-month turnaround from rejection by US FDA to approval for golodirsen, the second Sarepta DMD drug to clear the agency after appearing to have minimal prospects.

You may also be interested in...



A Tale Of Two DMD Drugs: Theme And Variation In Controversial US FDA Reviews

Despite obvious similarities in the contentious reviews of Sarepta’s Vyondys 53 and its predecessor Exondys 51, drug developers should focus on the differences between the two reviews.

US FDA Ends 2019 With Second-Highest Approval Count After Second-Half Rebound

CDER's 48 novel agents, including 35 in the second half of the year, marks the second-highest novel approval count in the contemporary era.

The Giroir FDA: Acting Tenure Ending Soon – But It Was Eventful

Brett Giroir’s tenure as acting commissioner of the US FDA won’t last long, but it has marked another high water mark in the pro-innovation climate at the agency, which is an important message about what FDA commissioners do – and don’t – actually do.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS141364

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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