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

Gilead, US FDA Ponder Innovative Designs For Descovy HIV Prevention Study In Women

Executive Summary

Advisory committee sent a clear message that pre-exposure prophylaxis studies are needed in cisgender women, but what those studies might look like, and whether the agency can exercise its statutory authorities to ensure they are conducted, is less clear.

You may also be interested in...



ViiV Thinks It May Get All-Gender Approval For Cabotegravir For PrEP

Final data comparing cabotegravir to Truvada for HIV prophylaxis confirms superiority. ViiV says treatment data in women may enable an all-gender approval that eluded Gilead with Descovy.

ViiV Thinks It May Get All-Gender Approval For Cabotegravir For PrEP

Final data comparing cabotegravir to Truvada for HIV prophylaxis confirms superiority. ViiV says treatment data in women may enable an all-gender approval that eluded Gilead with Descovy.

Keeping Track: US FDA, Industry Roar Into Fourth Quarter With Bevy Of Regulatory Announcements

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

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

ID034708

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