FDA accepts Sirion’s ophthalmic drug NDA
Sirion is seeking approval for Durezol (difluprednate ophthalmic emulsion) 0.05%, a twice-daily steroid, as a treatment for postoperative ocular inflammation. Priority review is granted by the FDA to
Amgen has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for Repatha (evolocumab) supporting its broader use prior to a first heart attack or stroke.