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


2010 FDA Advisory Committee Recommendations

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary


You may also be interested in...

Amgen’s risk plans for Nplate

Amgen's biologic Nplate (romiplostim) will have a Risk Evaluation and Mitigation Strategy that will include a comprehensive patient educational program plus financial assistance for those who cannot afford the drug, according to an Amgen release prematurely issued July 14, which states that the drug had been approved. Amgen later reports that FDA will miss the July 23 user fee date for the product, submitted for treatment of thrombocytopenia in adults with chronic immune thrombocytopenic purpura. The user fee had been pushed back from April 23 after the firm submitted an extensive risk management plan. Nplate is widely expected to gain approval shortly; FDA's Oncologic Drugs Advisory Committee voted unanimously in favor of the biologic in March (1Pharmaceutical Approvals Monthly June 2008)

Dendreon To File Provenge BLA In 2006 Based On Survival Data

Dendreon plans to submit a BLA for its prostate cancer vaccine Provenge in 2006 following FDA feedback suggesting that existing data is sufficient for filing, the firm says.

FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011





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