CMS Response to CATT Study Will Be Next Step in Defining Coverage Policy for Biopharma

Drug Review Dossier: dapagliflozin

Drug Review Dossier: Avastin for Breast Cancer

Drug Review Dossier: mirabegron

Drug Review Dossier: Benlysta

Advisory Committee Tracker: Early 2011 Agenda Features Broad Topics, Fewer Specific Products

FDA To Look-Back on Six Oncology Accelerated Approvals: Feb. 8 Meeting Reprises 2003 Event

Lilly/Avid's Amyvid Receives “Positive” Non-approval Vote: Future Holds Complete Response with Path to Approval for Flobetapir

Lilly/Avid’s Amyvid Beta-Amyloid Radiopharmaceutical Headed for “Complete Response” From FDA

FDA Releases Report on Transparency to Regulated Industry: Not Much To See Here

Drug Approvals in 2011: The Same Themes, But Fewer Applications

FDA and Biopharma: 2011 Will Be Year of Consolidation, Not Innovation, in Agency Policy

Sharfstein Out At FDA: Exit Positions Agency for GOP, Removes Internal Voice for Critics

FDA Releases Tentative List of 2011 Advisory Committee Meetings: Hep C in April?

Avastin: FDA Proposes Withdrawal of Breast Cancer Indication; Appeals Process Has CMS Implications

Avastin: FDA Proposes Withdrawal of Breast Cancer Indication; Appeals Process Has CMS Implications

Contrave Mid-Day Update: No Surprises for Orexigen So Far

Orexigen’s Contrave Recommended by FDA Panel; a Positive for Vivus Qnexa As Well

Roche/Genentech’s Avastin: FDA’s Decision and CMS Implications

Orexigen Contrave Advisory Committee Review: Key Issues Will Be Cardiovascular Safety and Seizure Risk

Advisory Committee Tracker: Two December Cancellations

Advisory Committee Trends: Drug Reviews Hit the Ceiling

FDA Advisory Committee Recommends Approval of Human Genome Sciences Benlysta

Human Genome Sciences Benlysta: FDA Advisory Committee Mid-Day Update

Benlysta Advisory Committee: Key Issue is Efficacy; Expect Recommendation With Caveats