AbbVie Announces Extension of Review for Supplemental New Drug Application of Upadacitinib for the Treatment of Moderate to Severe Atopic Dermatitis prnewswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from prnewswire.com Daily Mail and Mail on Sunday newspapers.
AbbVie Announces Extension of Review for Supplemental New Drug Application of Upadacitinib for the Treatment of Adults with Active Psoriatic Arthritis
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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.
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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.
AbbVie Slumps After FDA Extends Psoriatic Arthritis Drug Review thestreet.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from thestreet.com Daily Mail and Mail on Sunday newspapers.
AbbVie to Present at the Cowen 41st Annual Health Care Conference
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NORTH CHICAGO, Ill., Feb. 19, 2021 /PRNewswire/ AbbVie (NYSE: ABBV) will participate in the Cowen 41
st Annual Health Care Conference on Wednesday, March 3, 2021. Michael Severino, M.D., vice chairman and president, Robert A. Michael, executive vice president and chief financial officer, and Jeffrey R. Stewart, executive vice president, commercial operations, will present virtually at 10:40 a.m. Central time.
A live audio webcast of the presentation will be accessible through AbbVie s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.