USFDA

Y-mAbs Therapeutics, Inc. a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the U.S. Food and Drug Administration has approved DANYELZA (naxitamab-gqgk) 40mg/10ml.

Pfizer Inc. (NYSE: PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved XELJANZ® (tofacitinib) for the treatment of children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA). Two formulations were approved, a tablet and an oral solution, and are dosed based upon weight. This approval makes XELJANZ the first and only Janus kinase (JAK) inhibitor approved in the U.S. for the treatment of pcJIA.

Strides Pharma Science Limited (Strides) today announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/325 mg/40 mg from the United States Food & Drug Administration (USFDA).

Zydus Cadila has received final approval from the USFDA to market Cisatracurium Besylate Injection USP (US RLD: Nimbex ®) in the strength of 20 mg (base)/10 mL (2 mg/mL) Multiple-Dose Vial.