NORTH CHICAGO, Ill., April 23, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for VENCLYXTO® (venetoclax) in combination with hypomethylating agents for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. The positive CHMP opinion is a scientific recommendation for marketing authorization to the European Commission (EC), which is expected to deliver its final decision on VENCLYXTO combination therapy for use in AML in the first half of 2021.
NORTH CHICAGO, Ill., April 7, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it has submitted applications seeking approval for SKYRIZI® (risankizumab-rzaa, 150 mg) to the U.S. Food and Drug Administration (FDA) and for SKYRIZI® (risankizumab, 150 mg) to the European Medicines Agency (EMA) for the treatment of adults with active psoriatic arthritis.1 The submissions were supported by two pivotal Phase 3 studies, KEEPsAKE-1 and KEEPsAKE-2, which evaluated SKYRIZI in adults with active psoriatic arthritis including those who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying anti-rheumatic drugs (DMARDs).1
NORTH CHICAGO, Ill., April 7, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced new data from its expansive neuroscience portfolio will be presented at the 2021 American Academy of Neurology (AAN) Annual Meeting, to be held virtually from April 17-22. A total of 33 abstracts, including one podium presentation during the Clinical Trials Plenary Session and three oral presentations, will be shared from a broad range of studies across the spectrum of migraine, advanced Parkinson's disease and spasticity.
NORTH CHICAGO, Ill., April 2, 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 adults and adolescents with moderate to severe atopic dermatitis. The Prescription Drug User Fee Act (PDUFA) action date has been extended three months to early Q3 2021.
IRVINE, Calif., April 1, 2021 /PRNewswire/ -- Today, Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announces the launch of SkinMedica® Neck Correct Cream, the first product from the professional-grade skincare line formulated to address the specific biology of the skin on the neck and décolleté area. SkinMedica® Neck Correct Cream was designed to prevent the early signs as well as treat the visible appearance of moderate to severe neck aging. It is clinically proven to firm and tighten the look of crepey skin, prevent and reduce the look of sagging, smooth deep lines and wrinkles and enhance skin tone evenness.1
NORTH CHICAGO, Ill., April 1, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the New England Journal of Medicine has published 24-week results from the Phase 3 SELECT-PsA 1 trial evaluating RINVOQ™ (upadacitinib, 15 mg and 30 mg) in adults with active psoriatic arthritis who had responded inadequately or were intolerant to one or more non-biologic disease modifying anti-rheumatic drugs (DMARDs).1 These data build on previously announced Phase 3 topline results showing that upadacitinib 15 mg and 30 mg met the primary endpoint of ACR20 response at week 12 versus placebo as well as key secondary endpoints.1
NORTH CHICAGO, Ill., March 31, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) will announce its first-quarter 2021 financial results on Friday, April 30, 2021, before the market opens. AbbVie will host a live webcast of the earnings conference call at 8 a.m. Central time. It will be accessible through AbbVie's Investor Relations website investors.abbvie.com. An archived edition of the session will be available later that day.
NORTH CHICAGO, Ill., March 30, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for atogepant, an investigational orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant), for the preventive treatment of migraine in adults who meet criteria for episodic migraine. AbbVie anticipates a regulatory decision in late Q3 2021.
NORTH CHICAGO, Ill., March 17, 2021 /PRNewswire/ -- AbbVie, a global research and development-based biopharmaceutical company, today announced that the AbbVie CF Scholarship program is now accepting applications for the 2021-2022 academic school year. Eligible undergraduate and graduate students are invited to apply for the scholarship until April 30, 2021 at 11:00 a.m. U.S. eastern time by visiting www.AbbVieCFScholarship.com. Students can apply online or by downloading an application on the official scholarship website.
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.
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