FDA Triferic Meeting: Rockwell Gets Positive Vote for Iron Loss, Agency Gets Affirmation for Additional ESA-Sparing Studies

Novartis Panobinostat Rejected By FDA Panel; PFS Alone Appears Insufficient for Myeloma Approval

Actavis Antibiotic Combo May Set Precedents: FDA Panel To Review Literature NDA For Broad Use, Separate “Limited Use”

Drug Regulatory and Policy Environment Only Gets Better With Mid-Term Election Results

Rockwell’s Triferic Will Have To Overcome FDA Concern About “Missing Data,” Skepticism on Reducing ESA

Novartis Panobinostat for Multiple Myeloma: FDA Documents Offers Dim View Of Efficacy Based On PFS

Abuse-Deterrent Opioids: FDA Sees Multi-Step Process Towards Blanket Requirements For Tamper Resistance

Daiichi-Sankyo Edoxaban Clears Committee, But Labeling Likely To Reference Worse Outcomes In Patients With Normal Renal Function

Female Sexual Dysfunction Meeting Tests Resilience of FDA Patient Input Process, Sets Tone for Active NDA, Future Trials

Advisory Committee Tracker: Novartis Oncology Drug, Rockwell Iron Replacement Therapy Face Tough Test At ODAC

Adaptive Licensing in the US: EU Pilot Project, FDA Animal Drug Process Offer Potential Models For Upcoming Legislation

Daiichi Edoxaban For Atrial Fib: “Non-Inferiority” May Not Be Good Enough, But Approval For Renally Impaired Likely

FDA Aspergillosis Biomarker Qualification Coincides With Active NDA Review, Highlights New Drug Development Tool Process

Breast Cancer “Master Protocol” Meeting: FDA, Industry Not Barriers, But Other Stakeholders Need To Learn To Collaborate

Delaying, Denying, Refusing Inspection Revised Guidance Adds Examples of Reasonable Explanations

Vertex Wins Approval Vote For Broader Kalydeco CF Use; FDA Urges “Flexibility” For Known Drug, Known Disease

Advisory Committee Supports Novartis Secukinumab for Psoriasis; Largely Agrees With Proposed 300 mg Dose

Turning the Page on Zohydro? New Formulations, New Division Leadership Should Help FDA Move Forward in Opioids

Vertex Kalydeco CF Expansion Does Not Follow FDA’s Suggested Path, But Is Probably Sufficient For FDA Advisory Committee

Chantix Review: Pfizer Loses De Facto Appeal on Black Box; FDA Managers Ask What Neuro Events Justify Heightened Warning

CDER Office of Product Quality Raises Manufacturing Profile Within FDA, Poses Similar Challenge To Industry

Ebola Hearing Highlights FDA Flexibility, Pipeline Agents; Longer Term Impact May Be To Boost Incentives

Novartis Secukinumab Heads To Committee With Positive FDA Review; Dosing Issues May Be Only Stumbling Block

Novartis, Bristol, and Glaxo Lead In Breakthrough Designations As FDA Tally Approaches 70

FDA On Track For A Big Year In NME Approvals: Agency Could Top 40 By Year End