Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Keeping Track: US FDA Acts On 5 Novel Drugs: Approval For Fotivda, Pepaxto, Azstarys; CRLs For Defencath and Oral Paclitaxel

Executive Summary

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

You may also be interested in...



Pfizer Triples Down On CDK Inhibition In Breast, Other Cancers

Pfizer is looking to address breast cancer resistant to Ibrance and other CDK4/6 inhibitors, but sees potential paths to earlier lines of treatment and additional tumors.

Accelerated Approval: US FDA Panel To Reconsider Six Indications For Checkpoint Inhibitors

Oncologic Drugs Advisory Committee will meet for three days in April to consider whether indications for Tecentriq, Keytruda and Opdivo should remain on label despite failure to confirm clinical benefit; review is part of the Oncology Center of Excellence’s ‘industry-wide evaluation’ of accelerated approvals, which has led to withdrawals of four other PD-1/L-1 inhibitor claims.

Persistence Pays Off With US Approval Of Aveo’s Fotivda In RCC

The approval marks the first commercial launch for Aveo in the US, but tivozanib has shown modest efficacy in cancer and the approval is relegated to later lines.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS143995

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