Pharmaceuticals, Biotechnology and Life Sciences
Janssen has submitted a type II variation application to European Medicines agency, looking to get approved guselkumab, which could then…
The Janssen has filed for a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking first-in-class approval of guselkumab brand Tremfya, for the treatment of adult patients with active psoriatic arthritis (PsA), and expects to submit a marketing application to the European Medicines Agency seeking approval of TREMFYA as a treatment for PsA before the end of the year.
United States Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Pfizer’s Xeljanz (tofacitinib citrate) 5 mg twice daily (BID) and XeljanzXR extended release 11 mg once daily use the treatment of adult patients with active psoriatic arthritis (PsA).