Scrip 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

Further Analyses To Delay Ipsen’s Palovarotene Progress In Ultra-Rare Disease

Withdraws US Marketing Submission

Executive Summary

Ipsen has withdrawn the US NDA for palovarotene in an ultra-rare bone condition in order to conduct additional data analyses, but intends to resubmit once they are complete.

You may also be interested in...



Keeping Track: Merck & Co. In Spotlight With Welireg, Keytruda Approvals; FibroGen/AZ Roxadustat CRL Is No Surprise

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Ipsen Positive On Palovarotene Despite Troubled Past

Despite concerns over toxicity due to early growth plate closure in skeletally immature patients, Ipsen's CEO David Loew is confident that palovarotene will get through regulatory review for fibrodysplasia ossificans progressive.

Pipeline Watch: Phase III Readouts in Wilson Disease, Parkinson's Disease And COVID-19

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Topics

Related Companies

UsernamePublicRestriction

Register

SC144898

Ask The Analyst

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

Thank you for submitting your question. We will respond to you within 2 business days. 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