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

Angiomax “not approvable” for supplemental indication

Executive Summary

The Medicines Company's Angiomax is "not approvable" for percutaneous coronary intervention with thrombocytopenia or heparin-induced thrombocytopenia and thrombosis syndrome, FDA says. Agency found deficiencies in both the study methods and the analysis of clinical data in the application, TMC says June 3. The company says it will meet with FDA to discuss the issues raised in the letter...

Latest Headlines
See All
UsernamePublicRestriction

Register

PS044099

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