10.12.2012
Member Sign In:
Research Notes
- No categories
Regulatory Tracking
- No categories
All Research
Drug Review Tracker
Novartis Tobi Inhaler Wins Advisory Committee Support; Skeptical FDA Review Still An Issue
9.05.2012
Novartis Tobi Powder Inhaler Faces Skeptical FDA Review At Upcoming Advisory Committee Review
8.31.2012
Pfizer’s Tafamadis Faces Tough FDA Panel Review: Classic Test of Orphan Drug “Flexibility” at FDA
5.22.2012
Arena’s Lorqess Gets a Yes But Immediate Approval Unlikely; Vivus on Track for July Approval
5.10.2012
Arena’s Lorqess Returns to Committee: CV Outcomes Standard Likely to be Applied to Weight Loss Agent
5.08.2012
Pfizer’s Tofacitinib in RA: Difficult Panel Coming As Malignancy Risk Appears Key To Up or Down Vote
5.07.2012
GSK Votrient Sarcoma Use Clears FDA Committee 11-2; “Marginal” Benefit is More Than Enough
3.20.2012
Chelsea’s Northera: FDA Panel Overrules Reviewers But Another Study May Be Necessary Anyway
2.23.2012
Qnexa Gets To Yes: Vivus Weight Loss Drug Clears Advisory Committee; Outcomes Discussion Still Looms
2.22.2012
Vivus Qnexa Advisory Committee Preview: Risk Management Unsettled, CV Outcomes Vote Provisional
2.17.2012
Eisai’s Dacogen For AML: Panel Votes Down New Indication As Follow-Up Analysis Is Not Enough
2.09.2012
Qnexa Returns to FDA: Better Climate for Weight Loss Drug Review, But Better Outcome Unlikely
1.05.2012
FDA Advisory Committees Trending More Positive as 2013 Begins; New Review “Program” Will Impact Committee Dynamics