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


Agile’s Twirla Heads To Advisory Committee: No Mystery Why

Executive Summary

Contraceptive patch has had rocky regulatory path with US FDA. To Agile’s credit, the company pulls no punches in its shareholder filings in explaining the situation.

You may also be interested in...

Keeping Track Of User Fee Decisions And Filings: Adakveo, Brukinsa And Fetroja Mark Massive Week Of Novel Approvals

The latest news on US FDA user fee decisions and submissions to the agency.

Agile's Twirla Suffers Scathing Critique By US FDA Ahead Of Advisory Cmte.

Agile's transdermal contraceptive will go before the Bone, Reproductive and Urologic Drugs Advisory Committee as it nears the end of its third review cycle, although the agency appears ready to issue another complete response letter before it even hears from the panel.

Tired Of Winning? When It Comes To US FDA Appeals, “Denied” Can Still Mean Victory

Success rate for sponsors pursuing appeals of FDA rejections is much higher than reported by agency, a leading US regulatory law firm argues. Agile Therapeutics’ “loss” of an appeal is a good example of how sponsors can still benefit even if their formal request is denied.





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