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


ECG Contrast Agents May Get Warnings Reduced After Advisory Committee Review

This article was originally published in The Pink Sheet Daily

Executive Summary

Post-marketing studies requested for Lantheus Medical Imaging's Definity and GE Healthcare's Optison appear to point to lower cardiopulmonary risks than FDA had suspected when it asked the companies to add boxed warnings to the product labels in 2007.

You may also be interested in...

Acusphere’s Imagify Hit Hard With FDA Panel Rejection

Advisory committee cites myriad trial design, safety and efficacy concerns in overwhelmingly negative vote; Acusphere suspends Nasdaq trading.

FDA Hints At Additional Trials for Acusphere’s Imagify

Stocks plummet after FDA posts briefing documents detailing extensive safety concerns, and problems with efficacy data, before advisory committee meeting.

Cancer-Genomics Firm Quanticel Debuts With Close Ties To Celgene, And An Exit In Mind

Celgene will get exclusive use of Quanticel's single-cell genomic analysis to tweak its clinical pipeline, and it also has exclusive options to acquire the venture-backed start-up.





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