GSK’s Malaria Drug Tafenoquine Heads To US FDA Panel Review With Agency Backing
Approval could bring GlaxoSmithKline a tropical disease priority review voucher.
You may also be interested in...
GlaxoSmithKline has proposed to market and manufacture antimalarial Krintafel in India and an expert panel has sought additional information to progress a review of these plans. GSK and partner MMV aim to ensure that the cost of the therapy does not impede access.
The latest drug development news and highlights from our US FDA Performance Tracker.
Extended dosing required for prophylactic indication could raise more advisory committee concerns about safety than the one-time dose of GlaxoSmithKline’s formulation, which was recently approved for prevention of relapse.