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Xeljanz News
Four JAK Inhibitors Have Comparable Efficacy, Safety for RA
FRIDAY, Dec. 1, 2023 – For patients with rheumatoid arthritis, the efficacy and safety of four Janus kinase (JAK) inhibitors is comparable, according to a study published online Nov. 1 in...
JAK Inhibitors May Aid Hair Regrowth in Patients With Alopecia
WEDNESDAY, July 19, 2023 – Janus kinase (JAK) inhibitors are associated with more hair regrowth than placebo for patients with alopecia areata, according to a review published online June 27 in JAMA...
Treatment Effect of Tofacitinib, Adalimumab Compared in RA
WEDNESDAY, July 12, 2023 – For adults with rheumatoid arthritis (RA), there is a modest reduction in the mean Disease Activity Score in 28 joints using C-reactive protein (DAS28-CRP) at three months...
U.S. FDA Approves Pfizer’s Xeljanz (tofacitinib) for the Treatment of Active Ankylosing Spondylitis
NEW YORK--(BUSINESS WIRE) December 14, 2021 – Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for...
FDA Medwatch Alert: FDA Requires Warnings About Increased Risk of Serious Heart-Related Events, Cancer, Blood Clots, and Death for JAK Inhibitors That Treat Certain Chronic Inflammatory Conditions
This information is an update to the FDA Drug Safety Communication issued on February 4, 2021. FDA also previously communicated about the safety clinical trial with Xeljanz, Xeljanz XR (tofacitinib)...
FDA Medwatch Alert: Initial Safety Trial Results Find Increased Risk of Serious Heart-Related Problems and Cancer with Xeljanz, Xeljanz XR (tofacitinib)
February 4, 2021 – The U.S. Food and Drug Administration (FDA) is alerting the public that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems...
U.S. FDA Approves Pfizer’s Xeljanz (tofacitinib) for the Treatment of Active Polyarticular Course Juvenile Idiopathic Arthritis
NEW YORK--(BUSINESS WIRE) September 28, 2020 – Pfizer Inc. (NYSE: PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved Xeljanz® (tofacitinib) for the ...
FDA Approves Xeljanz XR (tofacitinib) Extended-Release Tablets for the Treatment of Ulcerative Colitis
December 12, 2019 - Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Xeljanz XR (tofacitinib) extended-release 11 mg and 22 mg tablets for the...
FDA Medwatch Alert: FDA Approves Boxed Warning About Increased Risk of Blood Clots and Death with Higher Dose of Tofacitinib (Xeljanz, Xeljanz XR)
July 26, 2019 – The U.S. Food and Drug Administration has approved new warnings about an increased risk of blood clots and of death with the 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz...
FDA Medwatch Alert: Safety Communication: Xeljanz, Xeljanz XR (tofacitinib) Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients
ISSUE: FDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was...
Pfizer Announces U.S. FDA Approves Xeljanz (tofacitinib) for the Treatment of Moderately to Severely Active Ulcerative Colitis
Wednesday, May 30, 2018 - Pfizer Inc. announced today that the United States (U.S.) Food and Drug Administration (FDA) approved Xeljanz (tofacitinib) 10 mg twice-daily (BID) for at least eight weeks,...
Pfizer Announces FDA Approval of Xeljanz (tofacitinib) and Xeljanz XR for the Treatment of Active Psoriatic Arthritis
December 14, 2017 - Pfizer Inc. (NYSE:PFE) announced today that the United States Food and Drug Administration (FDA) has approved Xeljanz 5 mg twice daily (BID) and Xeljanz XR (tofacitinib) extended...
Pfizer Announces FDA Approval of Xeljanz XR (tofacitinib citrate), the First and Only Once-Daily Oral JAK Inhibitor Treatment for Rheumatoid Arthritis
February 24, 2016 – Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Xeljanz XR (tofacitinib citrate) extended-release 11 mg tablets for the...
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Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis, Ulcerative Colitis