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Pfizer Inc : XELJANZ (tofacitinib citrate) Receives Marketing Authorization in the European Union for the Treatment of Active Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis

Pfizer Inc : XELJANZ (tofacitinib citrate) Receives Marketing Authorization in the European Union for the Treatment of Active Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis
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U S FDA Approves TICOVAC, Pfizer s Tick-Borne Encephalitis Vaccine

TICOVAC™ may help reduce the risk of TBE for people traveling to endemic areas, potentially including military personnel serving in these locations Pfizer Inc. today announced that the U.S. Food and Drug Administration has approved TICOVAC™ vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC™ is the only FDA-approved vaccine to help protect U.S. adults and children .

Pfizer Provides Update on U S FDA Review of Abrocitinib and XELJANZ® Filings

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 … Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has notified the company that it will not meet the Prescription Drug User Fee Act (PDUFA) 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 XELJANZ/XELJANZ XR (tofacitinib) for the treatment of adults with active ankylosing spondylitis. The FDA cited its ongoing review of Pf

Calls mount on FDA to formally endorse Covid vaccines as Delta surges

Calls mount on FDA to formally endorse Covid vaccines as Delta surges POLITICO 2 hrs ago By Lauren Gardner © Lisa Maree Williams/Getty Images A nurse administers the Pfizer vaccine to a client at the St Vincent s Covid-19 Vaccination Clinic on July 01, 2021 in Sydney, Australia. Pressure is growing for the FDA to grant full approval to the Pfizer and Moderna Covid-19 vaccines or to at least more clearly explain to the public its decision-making process to help convince more Americans to get their shots. Some medical experts have sounded off on social media in recent days, calling on regulators to endorse what they say the data already shows that the two vaccines by Pfizer-BioNTech and Moderna made with messenger RNA technology safely and effectively prevent severe illness, hospitalization and death from the coronavirus.

Data Published in New England Journal of Medicine Shows Pfizer s Tofacitinib Meets Primary Endpoint in Brazilian Study in Patients Hospitalized with COVID-19 Pneumonia

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 day 28 was 18.1% (26 of 144) with tofacitinib compared to 29.0% (42 of 145) 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 patients with an active serious infection

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