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FDA Regulatory Approval Updates
24 Oct 2025 22:25 GMT
… the add-on maintenance treatment of inadequately controlled chronic … biologic the FDA has approved for the treatment of … the FDA approved additional pediatric indications for YUFLYMA (adalimumab-aaty … are for the treatment of hidradenitis suppurativa …
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<![CDATA[Switch, Don’t Cycle: Upadacitinib Outperforms Adalimumab in RA Post-TNFi, With Eduardo Mysler, MD]]>
24 Oct 2025 05:04 GMT
… trial, have provided for the first time, clear, comparative data on treatment … MD, Executive Medical Director, Organizacion Medica de Investigacion, … Upadacitinib also outperformed adalimumab across additional ranked … head-to-head trials like SELECT-SWITCH …
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‘I hope this means more people can avoid years of constant discomfort and pain’: New treatment approach backed by Crohns patient
23 Oct 2025 17:13 GMT
… start regular treatments with biologic medications such as infliximab or adalimumab as soon … for patients.
Infliximab and adalimumab are existing drugs already used to treat … symptoms.
“It’s a very trial and error approach, but nothing …
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<![CDATA[Ustekinumab Linked to Lower 5-Year Cancer Risk vs Adalimumab in Psoriasis]]>
22 Oct 2025 16:14 GMT
… risk between the biologics of adalimumab, secukinumab, or ustekinumab. However, ustekinumab … a head-to-head randomized trial.
The sample included 2876 patients … .8% males).1
Previous treatments included methotrexate (adalimumab = 92.6%; secukinumab = 95 …
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Analysis of the Efficacy and Safety of Secukinumab Combined with Surgical Treatment for Hidradenitis Suppurativa: A Real-World Retrospective Study in China
22 Oct 2025 07:57 GMT
… TNF-α antagonists (such as adalimumab), IL-1 antagonists (such … US Food and Drug Administration (FDA) for the treatment of moderate- … 13 Both early clinical trials and real-world studies … completing 48W of treatment; (3) Irregular medication intake not adhering …
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FDA approves Yuflyma for two expanded indications
20 Oct 2025 18:08 GMT
… chronic inflammatory diseases.
The FDA approved expanded indications of … a press release.
Yuflyma (adalimumab-aaty, Celltrion, Inc.), approved … vice president and chief medical officer at Celltrion USA, … now able to provide treatment options for more patient …
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US FDA approves expanded paediatric indications for Celltrion’s Yuflyma and unbranded adalimumab-aaty
20 Oct 2025 12:13 GMT
… Food and Drug Administration (FDA) has approved expanded indications for Yuflyma (adalimumab-aaty … , senior vice president and chief medical officer at Celltrion USA. … access to high-quality, affordable treatments."
Yuflyma is a high …
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Making America a “Most-Favored Nation” for Drug Prices: Pfizer and AstraZeneca Step Up First
20 Oct 2025 05:43 GMT
… global pharmaceutical profits come from American taxpayers.
Drug manufacturers … billion investment in American biotech innovation from 2018- … advance wellness, prevention, treatments and cures that … $606
≈ 10 × higher
Humira (adalimumab 40 mg × 2 pens)
≈ …
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Celltrion Secures FDA Approval to Expand Yuflyma Pediatric Indications
20 Oct 2025 05:01 GMT
… Yuflyma (active ingredient: adalimumab) after receiving additional pediatric … U.S. Food and Drug Administration.
The newly … affordable price while providing treatment benefits equivalent to … product.
Recently, the FDA granted an interchangeability designation …
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Celltrion secures FDA approval for pediatric indications of Yuflyma
20 Oct 2025 04:22 GMT
… autoimmune disease treatment Yuflyma (ingredient: adalimumab), further enhancing … the world’s largest pharmaceutical market. The company … year, Celltrion received FDA approval for interchangeability between …
Humira, the originator drug, recorded global sales …