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U.S. FDA Approves RINVOQ® to Treat Adults and Children 12 Years and Older with Refractory, Moderate to Severe Atopic Dermatitis

ABBVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved RINVOQ ® (upadacitinib) for the treatment of moderate to severe atopic dermatitis in adults and children 12 years of age and older whose disease did not respond to previous treatment and is not well controlled with other pills or injections, including biologic medicines, or when use of other pills or injections is not recommended. 1 RINVOQ 15 mg once daily can be initiated in adults and children 12 years of age and older weighing at least 40 kg. 1 In these children and adults less than 65 years of age who do not achieve an adequate response, the dose may be increased to 30 mg once daily. 1

"Early in my career as an allergist, I saw how relentless the itch and rash could be for my patients with moderate to severe atopic dermatitis yet had limited options to offer those whose disease could not be adequately controlled with systemic therapy," said Thomas Hudson , M.D., senior vice president, research and development, chief scientific officer, AbbVie. "This additional approval for RINVOQ provides a once-daily oral option that can significantly improve the debilitating itch and skin symptoms of atopic dermatitis. It's also a proud moment for AbbVie as we continue our efforts to improve care in this disease state and other chronic, immune-mediated conditions."

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AbbVie Confirms Guidance of Greater Than $15 Billion in Combined Risk-Adjusted Sales for Rinvoq and Skyrizi in 2025

ABBVie (NYSE: ABBV) is confirming prior revenue guidance of greater than $15 billion in combined Rinvoq (upadacitinib) and Skyrizi (risankizumab) risk-adjusted sales in 2025. ABBVie now expects 2025 risk-adjusted sales of greater than $7.5 billion for Rinvoq and greater than $7.5 billion for Skyrizi. The new Rinvoq sales guidance is the result of lower expected Rinvoq sales in the U.S. following the recent label updates in approved indications, partially offset by higher anticipated sales in international markets, as well as higher anticipated global sales in Crohn's disease and ulcerative colitis following positive Phase 3 study readouts. The updated Skyrizi sales guidance is based on continued strong performance in psoriasis.

Forward-Looking Statements and Other Notices

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ACELYRIN Appoints Melanie Gloria as Chief Operating Officer

- ACELYRIN, INC., a biopharma company focused on providing patients life-changing new treatment options by identifying, acquiring, and accelerating development and commercialization of promising drug candidates, today announced the appointment of Melanie Gloria BSN, as the company's chief operating officer (COO). In this role, Ms. Gloria will oversee business operations across the company.

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