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Human medicines European public assessment report (EPAR): Usgena, ustekinumab, Status: Opinion
19 Sep 2025 10:30 GMT
… authorisation for the medicinal product Usgena, intended for the treatment of adults … quality, safety and efficacy to Stelara.
The full indications are:
Plaque … -biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate …
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J&J and Protagonist’s oral plaque psoriasis drug bests BMS’ Sotyktu
18 Sep 2025 23:05 GMT
… novel targeted oral peptide treatment has the potential to … biologic Stelara (ustekinumab) in the Phase III ICONIC-ASCEND trial … the US Food and Drug Administration (FDA) for icotrokinra in … you deserve! The Clinical Trials Arena Excellence Awards celebrate …
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Johnson & Johnson, Protagonist Study Shows Superior Skin Clearance In Psoriasis Trials
17 Sep 2025 21:06 GMT
… an oral pill, icotrokinra, compared to an injectable biologic, Stelara (ustekinumab), in … identified in the ICONIC-LEAD drug withdrawal/re-retreatment study …
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7 Common Crohn's Disease Medication Side Effects and How to Cope With Them
17 Sep 2025 00:15 GMT
… medication without talking to your doctor first. “We screen, monitor, and adjust treatment … Biologic drugs, like infliximab (Remicade), vedolizumab (Entyvio), and ustekinumab (Stelara), … the flu vaccine, shingles vaccine, and COVID-19 vaccine,” says Dhere …
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Essential Medicines List: WHO adds psoriasis biologics, sunscreen
16 Sep 2025 19:36 GMT
… Stelara (ustekinumab, Johnson & Johnson) were also added to the Essential Medicines … of Essential Medicines,” adalimumab and ustekinumab were added for the treatment of … that these medicines are to be used as “second-line treatment alternatives …
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FDA Allows First Biosimilar Without Clinical Efficacy Trials
11 Sep 2025 07:52 GMT
… biosimilar of Stelara (ustekinumab), an immunosuppressive drug used for … affordable access to biological medicines,” said Niazi, … treatment availability. The report recommends that the FDA … companies—not just multinational pharmaceutical firms—to compete. …
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Drug Makers And Payers To Blame For Biosimilar Barriers In U.S. Market
04 Sep 2025 21:01 GMT
… cost of expensive biologic medicines. However, biosimilars continue … amp; Johnson’s branded Stelara (ustekinumab) and referenced biosimilars … Others have been FDA-approved but aren’t … pharmaceuticals and particularly with respect to biosimilars. Drug …
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Celltrion launches Stelara and Xolair copycats in Australia, eyes 2026 follow-ons
04 Sep 2025 09:11 GMT
… ), a biosimilar to Janssen’s Stelara for autoimmune diseases, and Omlyclo … hospital tenders while partner Arrotex Pharmaceuticals drives pharmacy sales, aligning with …
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FDA to Waive Clinical Efficacy Studies for Monoclonal Antibody Biosimilars
02 Sep 2025 22:38 GMT
… pharmaceutical innovation and health care.1
Biosimilars are biologic medications … to the drug name. These are FDA-mandated because … these trials is to identify that the investigational treatment is … Stelara (ustekinumab) will be the first filed with the FDA …
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Johnson & Johnson (JNJ)’s Carvykti Sales Skyrocket 100% Amid Specialty Medicine Growth
02 Sep 2025 07:49 GMT
… :JNJ), a global leader in pharmaceuticals, medical devices, and consumer health, continues … the pharmaceutical front, Johnson & Johnson (NYSE:JNJ)’s Innovative Medicine segment … the loss of exclusivity for Stelara. The business’s robust pipeline …