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

Incyte’s Retifanlimab Tests US FDA’s Tolerance For Low Response Rates In Accelerated Approval

Executive Summary

US FDA advisory committee votes 13-4 to wait for Phase III data in anal cancer, expected in 2025.

You may also be interested in...



Rx For Immuno-Oncology Excess? Top US FDA Cancer Officials Take On Development ‘Wild West’

Rapid, uncoordinated growth has turned the PD-1/L1 inhibitor pipeline into a global stampede, FDA’s Pazdur and Beaver say. Solutions like a unified submission pathway and coordinated trial design pose challenges requiring international cooperation among governments and industry alike.

Gilead’s First-In-Class Drug For Aggressive Breast Cancer On Track For EU Approval

EU reviewers have recommended five new medicines and a pneumococcal vaccine for EU-wide approval. New uses of several approved medicines have also drawn the thumbs up, while the sponsor of a cancer drug has withdrawn its product from the review process.

Keeping Track: US FDA Clears Bylvay, Fexinidazole, Gives Retifanlimab CRL; JAK Inhibitor Class Delays

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

Related Content

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS144540

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