Arthritis

The 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...

The 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...

The 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...

AbbVie 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...

AbbVie 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)...

The 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...

The 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...

The 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...

Novartis 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...

The 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...

Yesterday, 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...

AbbVie 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,...

Canada’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...

When it comes to treating chronic, immune-mediated diseases, the standard course is to wait for symptoms before beginning treatment. But by that point, it may be too late for intervention. These diseases can silently do irreversible damage, according to Provention Bio Inc (NASDAQ: PRVB) CEO...