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Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for

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Pfizer Inc. (NYSE: PFE) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a

CHMP also recommends XELJANZ (tofacitinib) approval for the treatment of adults with active ankylosing spondylitis Pfizer Inc. (NYSE: PFE) today announced that the European Medicines Agency's

Pfizer Inc. announced today that the European Commission has approved XELJANZ ® for the treatment of active polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis in patients two years of age and older who have responded inadequately to previous therapy with disease modifying antirheumatic drugs . Two formulations were approved, a tablet and a new oral solution . XELJANZ is the first and only ...

Pfizer Provides Update on U.S. FDA Review of Abrocitinib and XELJANZ® Filings Pfizer Inc. announced today that the U.S. Food and Drug Administration has notified the company that it will not meet the Prescription Drug User Fee Act goal dates for the New Drug Application for abrocitinib for the treatment of adults and adolescents with moderate to severe atopic dermatitis and the supplemental New Drug Application for XELJANZXELJANZ XR for the treatment of adults with active ankylosing … Pfize...

Trial demonstrates cumulative incidence of death or respiratory failure through day 28 was 18.1% with tofacitinib compared to 29.0% with placebo, in hospitalized patients with COVID-19 pneumonia Multi-center, randomized, double-blind, placebo-controlled trial conducted across 15 sites in Brazil Tofacitinib is not approved or authorized for the treatment of COVID-19 patients. Tofacitinib should not be used in … Trial demonstrates cumulative incidence of death or respiratory failure through da...

Pfizer Announces Extension of Review of New Drug Application of Abrocitinib for the Treatment of Moderate to Severe Atopic Dermatitis Pfizer Inc. today announced that the U.S. Food and Drug Administration has extended the priority review period for the New Drug Application for abrocitinib for the treatment of adults and adolescents with moderate to severe atopic dermatitis. The Prescription Drug User Fee Act goal date has been extended three months to early Q3 2021. The FDA has also extended th...

Date Time Share Pfizer Announces Extension of Review of New Drug Application of Abrocitinib for Treatment of Moderate to Severe Atopic Dermatitis NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has extended the priority review period for the New Drug Application (NDA) for abrocitinib for the treatment of adults and adolescents with moderate to severe atopic dermatitis. The Prescription Drug User Fee Act (PDUFA) goal date has...

1.48 (1.04, 2.09)**** BID=twice daily; CI=confidence interval; HR=hazard ratio; IR=incidence rate; NMSC=non-melanoma skin cancer; TNFi=Tumor Necrosis Factor inhibitor. (*) Based on Cox proportional hazard model (**)The 10 mg BID treatment group includes patients that were switched from 10 mg BID to 5 mg BID as a result of a study modification in February 2019. (***) The risk period included all available follow-up regardless of treatment exposure. (****) The non-inferiority criterion was not me...