Nine PDUFA dates on FDA’s December calendar

FDA has set target action dates for at least nine applications this month, including three for rare diseases and one for a subcutaneous formulation of Opdivo.

The first rare disease therapy up for approval in December is olezarsen, a POCIII-targeting antisense therapy from  Ionis Pharmaceuticals Inc. (NASDAQ:IONS). Thirty-five years after the biotech’s founding, an approval of the therapy would complete Ionis’ transformation to an independent commercial company. ...