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

How The Avastin Appeal Will Proceed

You may also be interested in...



Safety Concerns Over Larger Bottle For ISTA's Bromday Could Impact Other Eye Drugs

FDA's Center for Drug Evaluation and Research refused to approve ISTA's sNDA for a larger fill size of the topical non-steroidal anti-inflammatory because it does not believe a single bottle should be used to dose drug in both eyes.

ODAC Will Have Bigger Role At Avastin Hearing Than Previously Described

FDA tells the Oncologic Drugs Advisory Committee it will have a voting role at the two-day hearing, in contrast with CDER's original expectation that the panel would provide advice and recommendations but not vote.

Avastin Data, Policy Implications Warrant Hearing On Breast Cancer Use, Genentech Tells FDA

Genentech has come out fighting on multiple fronts in its attempt to retain Avastin’s breast cancer indication, proposing a new confirmatory study, submitting new Phase IV data and attacking FDA’s interpretation of both the underlying scientific data and its regulations on withdrawal.

Related Content

Topics

UsernamePublicRestriction

Register

PS052961

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