FDA approval of Novartis AG's Farydak as a third-line multiple myeloma therapy was a regulatory salvage mission, made possible by a loophole.
FDA Used Regulatory Loophole To Save Novartis' Farydak
FDA shoehorned third-line multiple myeloma therapy into accelerated approval program using loophole in concept of unmet medical need; maneuver also gave agency ability to define a do-over of development plan.