Your search for tofacitinib returned 19 results

The applications are supported by data from two 2two phase 3 induction studies and one 1 maintenance study.

The ORAL Shift study enrolled 694 RA patients who were inadequate responders to methotrexate alone.

The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for upadacitinib (AbbVie), an investigational oral JAK1-selective inhibitor, for the treatment of moderate to severe rheumatoid arthritis (RA).

An anticipated Prescription Drug User Fee Act (PDUFA) action date of December 2017 has been set by the FDA for both Xeljanz sNDAs.

Pfizer announced top-line results from OCTAVE Sustain, the third Phase 3 study of Xeljanz (tofacitinib citrate) for the potential treatment of patients with moderately to severely active ulcerative colitis (UC).

Pfizer announced detailed results from the first 2 pivotal Phase 3 trials of the OCTAVE program evaluating oral tofacitinib 10mg twice daily in inducing remission in adults with moderately to severely active ulcerative colitis (UC). Findings were orally presented at the 11th Congress of ECCO Scientific Session.

The FDA has issued a Complete Response Letter (CRL) for the supplemental New Drug Application (sNDA) for Xeljanz (tofacitinib citrate; Pfizer) for the treatment of adults with moderate to severe chronic plaque psoriasis.

Pfizer announced top-line results from two Phase 3 induction trials of tofacitinib for the treatment of adults with moderate to severe ulcerative colitis (UC).

Pfizer announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Xeljanz (tofacitinib citrate) 11mg once daily modified release tablets for the treatment of moderate to severe rheumatoid arthritis in patients with inadequate response or intolerance to methotrexate.

Pfizer announced results from two Phase 3 studies from the Oral treatment Psoriasis Trials (OPT) program for tofacitinib citrate in adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.