By Colin Kellaher AbbVie Inc. on Friday said a Phase 3 study of its antipsychotic drug Vraylar as an adjunctive treatment for major depressive disorder met its primary endpoint, and that it. | October 29, 2021
NORTH CHICAGO, Ill., Oct. 2, 2021 /PRNewswire/ AbbVie today announced new data on the investigational use of risankizumab in Crohn s disease, upadacitinib in ulcerative colitis and. | October 3, 2021
By Stephen Nakrosis AbbVie Inc. on Tuesday said the U.S. Food and Drug Administration approved Qulipta for the preventive treatment of episodic migraine in adults. The company said. | September 29, 2021
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NORTH CHICAGO, Ill., May 24, 2021 /PRNewswire/ Late-breaking data analyses presented by AbbVie (NYSE: ABBV) at Digestive Disease Week
® (DDW) Virtual Conference 2021 showed significantly greater proportions of patients with moderately to severely active Crohn s disease treated with both doses of investigational risankizumab (600 mg or 1200 mg) met the co-primary endpoints of clinical remission and endoscopic response at week 12 compared to placebo (p
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NORTH CHICAGO, Ill., March 17, 2021 /PRNewswire/ AbbVie (NYSE:ABBV), a global research and development-based biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for upadacitinib in the treatment of adult patients with active psoriatic arthritis. The updated Prescription Drug User Fee Act (PDUFA) action date has been extended three months to late Q2 2021.
AbbVie recently received an information request from the FDA for an updated assessment of the benefit-risk profile for upadacitinib in psoriatic arthritis. AbbVie responded to the request and the FDA will require additional time for a full review of the submission.