InterMune’s Pirfenidone: FDA Review Gives Advisory Committee Leeway For Positive Recommendation, But Significant Uncertainty Remains

FDA Shakes Up Office of Generic Drugs

Novartis Menveo Meningitis Vaccine Clears FDA; Pfizer Prevnar-13 Down To the Wire for ACIP

Prevnar-13 Goes Down To the Wire at FDA; But Pfizer Finds Big Win after Finish Line

Avandia Investigation Puts Withdrawal in Play, Carries Broader FDA Implications

Dendreon’s Provenge: Don’t Count On Action Without An Advisory Committee

FDA Snow Delays: Agency To Extend Drug Review Deadlines For Near-Term Applications

Lovenox Generic Decisions Pending: Context and Background

Pharma/Biotech Health Reform Update: Drug Industry On Alert For Legislative Movement

Obesity Therapies in 2010: Tough To See Path To FDA Approval

FDA FY2011 Budget Includes Follow-On Biologics; As Many As Five Applications?

Opioid Drugs: FDA Limiting New Approvals Pending Class-Wide Postmarket Controls Decision

Picking Up The Pieces: Still Positive Options For Pharma/Biotech Manufacturers After Massachusetts Senate Election

Follow-On Biologics Provisions at Risk, But Pharma Deal Likely To Hold

Pharma Asked To Increase Contribution By $10 Bil.; A Positive Deal For Brand Makers

The New FDA: A New Law and New Leadership Mean More Timely Reviews and More Approvals

Handicapping Drug Approvals: Five Points to Consider

Key Biopharma Policy Issues for 2010

HGS Benlysta NDA Filing Coming Soon: Expect Nine Month Review