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AbbVie Scores FDA Approval For Its Blockbuster Drug Rinvoq To Treat Type Of Arthritis
Tuesday, April 29, 2025 - 2:34pm | 534The U.S. Food and Drug Administration on Tuesday approved AbbVie Inc.’s (NYSE:ABBV) Rinvoq (upadacitinib), 15 mg, once daily, for giant cell arteritis (GCA). GCA is an inflammation of blood vessels, called arteries, in and around the scalp. Earlier in April, the European Commission approved...
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Cannabis Linked To Diabetes Prevention And Better Blood Sugar Control, New Study Finds
Sunday, July 7, 2024 - 1:38pm | 675People who use cannabis, per the study, have healthier body responses to inflammation, better control of blood sugar levels and are often more active compared to those who don’t. These factors together could reduce the risk of developing diabetes, according to new research undertaken in a...
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Novartis' Cosentyx Scores FDA Approval For Arthritis In Children, Adolescents
Thursday, December 23, 2021 - 9:21am | 328The FDA has approved Novartis AG's (NYSE: NVS) Cosentyx (secukinumab) for active enthesitis-related arthritis (ERA) in four years and older, and active juvenile psoriatic arthritis (JPsA) in patients two years and older. Cosentyx is now the first biologic indicated for ERA...
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Europe Approves AbbVie's Skyrizi For Second Indication
Wednesday, November 17, 2021 - 11:59am | 220The European Commission (EC) has approved AbbVie Inc's (NYSE: ABBV) Skyrizi (risankizumab) 150 mg subcutaneous injection for psoriatic arthritis in adults. The approval covers Skyrizi alone or combined with methotrexate (MTX) for active psoriatic arthritis in adults who have had...
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AbbVie Touts Additional Rinvoq Data In Inflammatory Spinal Arthritis
Thursday, October 7, 2021 - 12:49pm | 342AbbVie Inc (NYSE: ABBV) has churned out new data for Rinvoq in the hope that adding more evidence will back the JAK inhibitor's megablockbuster potential. Related: AbbVie Submits Upadacitinib Applications In US, Europe For Ulcerative Colitis. The first study, part of the...
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AbbVie Unveils New Durable Risankizumab Data In Psoriatic Arthritis
Thursday, September 30, 2021 - 3:02pm | 192AbbVie Inc (NYSE: ABBV) announced new Phase 3 data analyses of KEEPsAKE-1 and KEEPsAKE-2, evaluating Skyrizi (risankizumab) in adults with active psoriatic arthritis for one year (52 weeks). The results were presented at the European Academy of Dermatology and Venereology (EADV)...
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Pfizer's Arthritis Drug Wins European Approval In Pediatric & Adult Patients
Monday, August 23, 2021 - 8:25am | 215The European Commission (EC) has approved Pfizer Inc's (NYSE: PFE) Xeljanz (tofacitinib) for active polyarticular juvenile idiopathic arthritis (JIA) and juvenile psoriatic arthritis (PsA). The approval covers two years of age and older patients who did not respond to...
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FDA To Miss Action Dates For AbbVie's Upadacitinib Application For Psoriatic Arthritis, Ankylosing Spondylitis
Friday, June 25, 2021 - 1:33pm | 314The FDA will not meet action dates for AbbVie Inc's (NYSE: ABBV) supplemental marketing applications for Rinvoq (upadacitinib) for active psoriatic arthritis and adults with active ankylosing spondylitis. The FDA cited its ongoing review of Pfizer Inc's...
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FDA Gives Emergency Use Nod For Roche's Arthritis Drug Against Severe COVID-19
Friday, June 25, 2021 - 8:19am | 157The FDA has approved Roche Holding AG's (OTC: RHHBY) arthritis drug Actemra (tocilizumab) for emergency use to treat adults and pediatric patients hospitalized with COVID-19. It was already allowed to be administered on compassionate grounds. The drug can be used to treat...
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Novartis's Late-stage Study On Cosentyx Hits Primary Endpoint Goal In Juvenile Idiopathic Arthritis
Wednesday, June 2, 2021 - 7:05am | 190Novartis AG (NYSE: NVS) said that the Phase 3 JUNIPERA study met its primary endpoint, with Cosentyx (secukinumab) showing a significantly longer time to worsening of symptoms compared to placebo in pediatric patients with two subtypes of juvenile idiopathic arthritis (JIA). The data...
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Supreme Court Rebuffs Novartis Appeal Over Amgen's Arthritis Drug Enbrel: Report
Monday, May 17, 2021 - 4:37pm | 362The Supreme Court turned away a petition from Sandoz seeking to challenge two Amgen Inc (NASDAQ: AMGN) patents related to rheumatoid arthritis drug Enbrel, thus blocking Novartis AG’s (NYSE: NVS) Sandoz from selling a biosimilar of the drug in the U.S...
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Analysts React To FDA AdCom Vote On ChemoCentryx's Avacopan, Stock Plunges
Friday, May 7, 2021 - 10:17am | 421Yesterday, the FDA’s Arthritis Advisory Committee panelists went through cloudy data while complaining about the design of the Phase 3 trial for ChemoCentryx Inc’s (NASDAQ: CCXI) avacopan. After going over time, they ended up without consensus. This orphan drug has...
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AbbVie Files US, Europe Applications For Skyrizi In Psoriatic Arthritis
Wednesday, April 7, 2021 - 10:42am | 155AbbVie Inc (NYSE: ABBV) has submitted marketing applications to the FDA and European Medicines Agency (EMA) seeking approval for Skyrizi (risankizumab-rzaa, 150 mg) for the treatment of adults with active psoriatic arthritis. In the Phase 3 KEEPsAKE-1 and KEEPsAKE-2 studies,...
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Pfizer's Xeljanz Under Health Canada's Scrutiny For Safety Risks
Wednesday, April 7, 2021 - 9:30am | 225Canada’s health regulator was launching a probe into Pfizer Inc’s (NYSE: PFE) arthritis drug, Xeljanz and Xeljanz XR (tofacitinib), after a trial by the company identified an increased risk of serious heart-related issues and cancer in the participants. The...
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AbbVie Shares Drop As Review For Upadacitinib US Application In Psoriatic Arthritis Pushed Back For Three Months
Wednesday, March 17, 2021 - 9:41am | 225The FDA has extended the review period AbbVie Inc's (NYSE: ABBV) supplemental marketing application for upadacitinib to treat adult patients with active psoriatic arthritis. The updated action date has been extended three months to late Q2 2021. AbbVie was recently asked to...