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Ustekinumab News
Celltrion Announces U.S. FDA Approval of Additional Presentation of Steqeyma (ustekinumab-stba), Expanding Dosing Options for Pediatric Patients
INCHEON, South Korea, June 15, 2025 -- Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a new presentation of Steqeyma® (ustekinumab-stba), a biosimilar t...
FDA Grants Interchangeable Designation to Fresenius Kabi’s Biosimilar Otulfi (ustekinumab-aauz)
LAKE ZURICH, Ill., May 19, 2025 – Fresenius Kabi, an operating company of Fresenius, and Formycon AG, announced today that the U.S Food and Drug Administration (FDA) designated Otulfi (u...
FDA Approves Starjemza (ustekinumab-hmny), a Biosimilar to Stelara
Guangzhou and London – May 27, 2025 – Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets and Hikma Pharm...
Teva and Alvotech Announce FDA Approval of Interchangeability for Selarsdi (ustekinumab-aekn) with Stelara (ustekinumab)
PARSIPPANY, N.J. & REYKJAVÍK, Iceland, May 05, 2025 (GLOBE NEWSWIRE) – Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Alvotech (NASDAQ: ...
FDA Approves Steqeyma (ustekinumab-stba), a Biosimilar to Stelara
JERSEY CITY, N.J., Dec. 17, 2024 – Celltrion announced today that the U.S. Food and Drug Administration (FDA) has approved Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab), for...
FDA Approves Yesintek (ustekinumab-kfce), a Biosimilar to Stelara
Bengaluru, Karnataka, India, December 01, 2024 -- Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), announced ...
Monthly News Roundup - October 2024
FDA Approves AbbVie’s Vyalev to Treat Advanced Parkinson Disease In October, the US Food and Drug Administration (FDA) approved Vyalev (foscarbidopa and foslevodopa) for the treatment of motor f...
Alvotech and Teva Announce U.S. FDA Approval of Additional Presentation of Selarsdi (ustekinumab-aekn), Expanding its Label to Include Further Indications Approved for Reference Product, Stelara (ustekinumab)
REYKJAVIK, Iceland & PARSIPPANY, N.J., Oct. 22, 2024 (GLOBE NEWSWIRE) – Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE:...
FDA Approves Imuldosa (ustekinumab-srlf), a Biosimilar to Stelara
RALEIGH, N.C., Oct. 14, 2024 /PRNewswire/ – Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care...
FDA Approves Pyzchiva (ustekinumab-ttwe), a Biosimilar to Stelara
Basel, July 1, 2024 – Sandoz, the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) has approved biosimilar Pyzchiva®* (u...
FDA Approves Selarsdi (ustekinumab-aekn), a Biosimilar to Stelara
REYKJAVIK, Iceland & PARSIPPANY, N.J.--(BUSINESS WIRE) April 16, 2024 --Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE:...
FDA Approves Wezlana (ustekinumab-auub), an Interchangeable Biosimilar to Stelara
October 31, 2023 – Today, the U.S. Food and Drug Administration approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory...
Stelara (ustekinumab) Approved by the U.S. Food and Drug Administration to Treat Pediatric Patients with Active Psoriatic Arthritis
As the first and only biologic targeting both cytokines interleukin (IL)-12 and IL-23, Stelara provides a new therapeutic option for children six years of age and older living with active psoriatic...
FDA Approves Stelara (ustekinumab) for Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis
HORSHAM, Pa., July 30, 2020 /PRNewswire/ – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded...
Janssen Announces FDA Approval of Stelara (ustekinumab) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis
HORSHAM, PENNSYLVANIA, October 21, 2019 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration’s (FDA) approval of Stelara (ustekinumab) for ...
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