Supplemental NDA submitted to FDA for Fanapt (iloperidone) as maintenance treatment for schizophrenia-Vanda Pharma

Aurinia Pharmaceuticals Inc. announced that the FDA has approved a label update for Lupkynis. The updated label no longer includes language indicating that the safety and efficacy of Lupkynis has not been established beyond one year. 

Merck Inc., known as MSD outside of the United States and Canada, announced that the Phase III KEYNOTE-811 trial evaluating Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy met its dual primary endpoint of overall survival (OS) for the first-line treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.