Mon-16-09-2019, 13:33 PM
Update:
They also expect to submit a marketing application to the European Medicines Agency seeking approval of Tremfya as a treatment for psoriatic arthritis (PsA) before the end of the year.
Quote:
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking first-in-class approval of Tremfya (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA).
They also expect to submit a marketing application to the European Medicines Agency seeking approval of Tremfya as a treatment for psoriatic arthritis (PsA) before the end of the year.