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

Lineup Of US FDA’s Potential Novel Approvals In H2 2021

Executive Summary

Our interactive table details the novel agents with user fee goal dates before the end of the year.

You may also be interested in...



Finance Watch: Venture Capital, Debt Financings Led Fundraising Surge In Q2

New VC deals include a $60m series C-1 round for DiCE Molecules a day before it filed paperwork to support a $100m IPO and a $100m financing for China’s IONOVA Life Science. Also, RenovoRx was the 84th company to go public in the US this year and ADC Therapeutics executed a $325m royalty deal. 

US FDA’s Novel Approval Count Hits 32 In First Half Of 2021, With More Than 40 Goal Dates Ahead

CDER approved a record 27 novel agents between January and June, while a wave of cell therapy and vaccine applications could carry the biologics center to new heights. Merck could close year with four novel approvals.

Keeping Track: Enhertu, Nubeqa Grow With RTOR; Interchangeable Cimerli And Another Nuplazid CRL

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

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS144589

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