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

Recent And Upcoming FDA Advisory Committee Meetings

Executive Summary

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

You may also be interested in...



InfaCare’s Stannsoporfin For Jaundice Rebuked By US FDA Panel

Uncertainties about clinical benefit and neurodevelopmental safety drive lopsided recommendation against approval; some advisory committee members say that even FDA’s REMS proposal wouldn't be enough to allow stannsoporfin to come to market without further studies.

Plazomicin's BSI Indication Gets 'No' From Advisory Panel, But US FDA Still Might Approve Under LPAD Pathway

Achaogen should at least be reassured by advisory committee's unanimous 'yes' vote for plazomicin's cUTI indication. 

Animals Rule: SIGA’s Smallpox Drug Tecovirimat Sails Through US FDA Panel

Antiviral wins unanimous endorsement on strength of efficacy data in two animal models and absence of major safety concerns in humans. FDA's advisors also see potential utility in other orthopoxviruses, particularly naturally occurring monkeypox outbreaks in Africa.

Related Content

Topics

UsernamePublicRestriction

Register

PS123018

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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