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: US FDA Approves Novel Tetracyclines Nuzyra And Seysara; Hemlibra Indication Expands

Executive Summary

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

You may also be interested in...



Deal Watch: Genentech Sees Bicycle As Route To Novel Targeted Cancer Immunotherapies

Genentech pays $30m up front in a collaboration with Bicycle in a deal that could bring the UK biotech roughly $1.7bn in total. Also, deals involving Nimble, Seattle Genetics, Five Prime, Fresenius, Vifor, Yuhan, Imnewrun, Paratek, Almirall, MBD, AzothBio, Norgine, Faes, Aspen Pharmacare, Swixx.

Biosimilars: US FDA Ends FY 2019 With Record Number Of Approvals, One Complete Response Letter

Agency approved 11 biosimilars from six sponsors with only one publicly disclosed complete response letter (Tanvex’s filgrastim). Pink Sheet infographic shows 351(k) application submission, approval and CRL rates over the life of the user fee program.

Keeping Track: Turalio, Nubeqa And Accrufer Mark Trio Of Novel Drug Approvals

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

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS124022

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