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A service for healthcare industry professionals · Sunday, December 22, 2024 · 771,060,158 Articles · 3+ Million Readers
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Ustekinumab News Monitoring

  • Published on Dec 21, 2024

    FDA Approves Seventh Ustekinumab Biosimilar to Reference Stelara

    Ustekinumab-stba (Steqeyma), the seventh biosimilar to reference ustekinumab (Stelara), was approved by the FDA for both adult and pediatric patients with plaque psoriasis and psoriatic arthritis as well as adult patients with Crohn disease and ulcerative …

    Source: The American Journal of Managed Care - Neutral
  • Published on Dec 21, 2024

    The Top 5 Most-Read Gastroenterology Articles of 2024

    The top gastroenterology biosimilar stories of 2024 highlight Skyrizi surpassing Humira in sales, raising concerns over "product hopping" potentially limiting biosimilar adoption. Despite several US adalimumab biosimilar launches in 2023, uptake …

    Source: The Center for Biosimilars - Label Pending
  • Published on Dec 19, 2024

    FDA Approves Seventh Ustekinumab Biosimilar, Steqeyma

    The US Food and Drug Administration (FDA) has approved ustekinumab-stba (Steqeyma) as a biosimilar to the interleukin-12 and -23 inhibitor ustekinumab (Stelara) for the treatment of adults with active Crohn’s disease or ulcerative colitis and for both …

    Source: Medscape - Neutral
  • Published on Dec 18, 2024

    FDA Approves Seventh Stelara Biosimilar, Steqeyma

    The FDA has approved Celltrion’s Stelara biosimilar Steqeyma (CT-P43), for adult and pediatric patients with plaque psoriasis and active psoriatic arthritis as well as adults with Crohn’s disease and ulcerative colitis, according to a recent news release. …

    Source: Formulary Watch - Label Pending
  • Published on Dec 18, 2024

    FDA Approves Seventh Ustekinumab Biosimilar

    The FDA has approved Celltrion’s CT-P43/ustekinumab-stba under the name Steqeyma, an ustekinumab biosimilar, for subcutaneous injection or intravenous infusion for both adult and pediatric patients with plaque psoriasis (PsO) and active psoriatic …

    Source: HCPLive - Label Pending
  • Published on Dec 18, 2024

    FDA Approves Steqeyma: The Seventh Stelara Biosimilar

    The FDA has approved Steqeyma (ustekinumab-stba), Celltrion's biosimilar candidate referencing Stelara (ustekinumab), for the treatment of psoriatic conditions and inflammatory bowel disease (IBD).1 The approval represents the seventh biosimilar …

    Source: The Center for Biosimilars - Label Pending
  • Published on Dec 18, 2024

    Ustekinumab-stba Receives FDA Approval for Autoimmune Disorder and Inflammatory Bowel Disease

    Ustekinumab-stba (Steqeyma; Celltrion), a biosimilar to ustekinuma (Stelara; Janssen Biotech, Inc) received FDA approval for subcutaneous injection or intravenous infusion for the treatment of adult and pediatric patients with plaque psoriasis, arthritis, …

    Source: Pharmacy Times - Neutral
  • Published on Dec 18, 2024

    Celltrion's Steqeyma nabs FDA approval as seventh Stelara biosimilar

    December 18, 2024 1 min read Add topic to email alerts Subscribe We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio The FDA approved Steqeyma as the …

    Source: Healio News - Neutral
  • Published on Dec 17, 2024

    2024 Drug & Device Approvals in Review

    January 5, 2024 FDA approves berdazimer gel, 10.3% (Zelsuvmi) for the treatment of molluscum contagiosum in patients 1 year and older1 January 16, 2024 Dupilumab (Dupixent) label updated to include uncontrolled atopic dermatitis on hands and feet of …

    Source: Dermatology Times - Neutral
  • Published on Dec 18, 2024

    Celltrion Secures U.S. Approval for Autoimmune Disease Treatment 'STEQEYMA'

    Celltrion announced on December 18th that its biosimilar product 'STEQEYMA' (development name: CT-P43), which is a biosimilar of the autoimmune disease treatment 'Stelara' (ingredient: ustekinumab), has received marketing approval from the …

    Source: Korea IT Times - Neutral
  • Published on Dec 18, 2024

    U.S. FDA approves Celltrion's STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab)

    STEQEYMA (CT-P43) is approved for both adult and pediatric patients with plaque psoriasis (PsO) and active psoriatic arthritis (PsA) as well as adults with Crohn's disease (CD) and ulcerative colitis (UC) STEQEYMA is a strategic addition to Celltrion…

    Source: WFMZ - Pennsylvania - Neutral
  • Published on Dec 19, 2024

    Dong-A ST Secures European Approval for Stelara Biosimilar IMULDOSA

    – Global Market Expansion Accelerates with Back-to-Back FDA and EC Authorizations Article content SEOUL, South Korea — Dong-A ST (CEO: Jeong Jae-hoon, KRX: 170900) proudly announces that its Stelara biosimilar, IMULDOSA (Project Name: DMB-3115, Active …

    Source: Financial Post - Center-right
  • Published on Dec 18, 2024

    Eli Lilly’s Omvoh recommended by CHMP to treat Crohn’s disease in adults

    Eli Lilly’s Omvoh (mirikizumab) has been recommended by the European Medicines Agency’s human medicines committee to treat Crohn’s disease. The Committee for Medicinal Products for Human Use (CHMP) has recommended that the drug be used to treat adults with …

    Source: PMLiVE - Neutral
  • Published on Dec 18, 2024

    Dong-A ST wins European approval for Stelara biosimilar IMULDOSA

    Dong-A ST said Wednesday that its Stelara biosimilar, IMULDOSA (project name DMB-3115, ingredient: ustekinumab), has received marketing authorization from the European Commission (EC). The approval came approximately two months after receiving a positive …

    Source: Korea Biomedical Review - Neutral
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