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


Analysis Of Recent Drug Reviews Illuminates Path For Future NDAs

Executive Summary

Every month, F-D-C Reports' Pharmaceutical Approvals Monthly dissects a new drug review by FDA. Using FDA's own review documents, including the discipline reviews, decision memos, meeting minutes, e-mails, and other documents, the publication strives to illuminate the agency decision-making process.

You may also be interested in...

With Avastin Approval For Breast Cancer, Will More Patients Hit Price Cap?

FDA approval of Genentech's Avastin for first-line treatment of metastatic breast cancer may trigger the first significant trial of the biotech's Avastin patient assistance program, which caps annual drug expenditures at $55,000 for approved indications but has not seen much utilization by colorectal or non-small cell lung cancer patients

GSK Tykerb Priced At Discount To Herceptin In Metastatic Breast Cancer

GlaxoSmithKline is pricing its breast cancer therapy Tykerb at a slight discount to Genentech's Herceptin (trastuzumab) in the metastatic breast cancer setting

Shire Turns Attention To Vyvanse Two Years Before Adderall XL Generics

Shire will seek to transition patients from Adderall XR to its next-generation attention deficit/hyperactivity disorder drug Vyvanse prior to 2009, when Adderall XR generics are expected to launch

Related Content




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