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Xeljanz XR 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...
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...
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 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...
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Rheumatoid Arthritis, Ankylosing Spondylitis, Ulcerative Colitis, Psoriatic Arthritis