FDA Panel: Tolerating Approval Outliers Would Set ‘Dangerous Precedent’
An unprecedented wait for final FDA approval will drag on for two orphan lymphoma drugs, at least a little while longer, as the agency decides how to end the delays and prevent them from happening again. The dihydrofolate reductase inhibitor pralatrexate (Folotyn) received accelerated approval in 2009 and the histone deacetylase (HDAC) inhibitor belinostat (Beleodaq) […]