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.

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

Keeping Track: Seqirus Pandemic Flu Vaccine Approved; Trevena Resubmits Oliceridine

Executive Summary

The latest drug development news and highlights from our US FDA Performance Tracker.

You may also be interested in...



Formycon Delay Pushes Back Coherus’ Ranibizumab

Formycon and Bioeq’s US filing for a biosimilar ranibizumab rival to Lucentis has been delayed after the FDA requested further data following a manufacturing change. Rights to the biosimilar have been licensed exclusively to Coherus in the US.

Keeping Track: Ayvakit Approval, Keytruda Supplement, NME Submissions

The latest drug development news and highlights from our US FDA Performance Tracker.

Breaking Up With Breakthrough: Trevena And Tonix Lose Designation, But Continue With Pivotal Plans

US FDA rescinds breakthrough designations for Tonix’ PTSD therapy Tonyma and Trevena’s novel pain drug Olinvo after clinical trial disappointments – and after identifying other regulatory pathways to market.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS141664

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