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

“Use With Caution” Isn’t Specific Enough For Labeling, FDA Tells Merck At Vorapaxar Panel

Executive Summary

Advisory committee struggles to give a labeling recommendation for lightweight patients, who saw lower efficacy using the platelet inhibitor.

You may also be interested in...



FDA Panel Will Have To Resolve Bleeding Risk With Merck’s Vorapaxar

Novel antiplatelet product has suffered from excess bleeding rates in clinical trials and is searching for an appropriate patient population, after initial hopes of being a blockbuster.

Vaccine Distribution Priorities To Rely On Governors, Not ACIP, HHS Secretary Azar Says

Azar says ACIP’s prioritization recommendations should carry weight, but states will be final arbiter of who is vaccinated.

An Oversupply Of COVID Antibody Treatments? Multiple Monoclonal Products Raise Potential For Errors

As distribution of Regeneron’s monoclonal antibody treatment for coronavirus begins, OWS officials worry about provider confusion with Lilly’s product due to differences in preparation and administration.

Topics

Related Companies

UsernamePublicRestriction

Register

OM001644

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