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 Clears Vtama, But Not Bimekizumab Or Ycanth; Tibsovo Takes RTOR To Frontline AML Setting

Executive Summary

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

You may also be interested in...



Supplemental Filings: Ycanth Approved For Molluscum; CDER Counter-Terrorism Head Retires; 5 Benzodiazepines Added To Schedule I

The fourth review cycle is the charm for Verrica's cantharidin topical solution; Rosemary Roberts, head of CDER's Counter-Terrorism and Emergency Coordination Staff, retires after 35 years at the FDA; DEA deems five designer benzodiazepines with no currently accepted medical use in the US as Schedule I controlled substances.

Verrica Finally Gets Molluscum Treatment To The Finish Line

Verrica’s Ycanth, a drug-device combination product containing a formulation of cantharidin, is approved by the FDA as the first treatment for molluscum, after three complete response letters.

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.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS146253

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