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

Executive Summary

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

You may also be interested in...



Potential Blockbuster Lebrikizumab Among Latest Drugs Up For Decision On EU Approval

The European Medicines Agency  is set to decide whether to back EU marketing approval for eight new drugs.

Cool Down: US FDA’s July User Fee Calendar Suggests Slower Pace After Torrid June

FDA action is expected on a handful of novel agents, including Daiichi Sankyo’s quizartinib, and conversion to full approval for Eisai/Biogen’s Leqembi.

Keeping Track: Showers Of Approvals In US FDA’s May Forecast

Upcoming user fees include 16 novel agents, featuring two RSV vaccines, two gene therapies, and three oncologics. The Pink Sheet’s US FDA Performance Tracker breaks down the big month to come.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS146397

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