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FDA Drug Approvals Q3 2025
06 Jan 2026 17:43 GMT
… delivery of drug in the bladder for treatment of bacillus … no longer as adjunct to statin therapy)
Repatha (evolocumab)— … sublineage LP.8.1
Actemra (tocilizumab)— Indication for … illness in vaccine recipients; Vimkunya (chikungunya recombinant, vaccine) is …
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<![CDATA[Year in Review: FDA Expands Biosimilar Approvals Across Oncology, Immunology, and Bone Health]]>
24 Dec 2025 19:06 GMT
… progress in broadening treatment options, improving affordability … Pharmaceuticals) received FDA approval as a biosimilar to ustekinumab (Stelara; Janssen Biotech … by phase 3 trial data in … a biosimilar referencing tocilizumab (Actemra; Genentech) in both …
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<![CDATA[Emerging Data Push Antibody-Drug Conjugates Into Earlier Lines of Therapy in DLBCL ]]>
19 Dec 2025 19:17 GMT
… Medical College of Wisconsin in Milwaukee.
LOTIS-7 Trial Design
Emerging trials … by the FDA and European Medicines Agency for … antipyretics, requiring tocilizumab (Actemra) less frequently than … -drug conjugate loncastuximab tesirine for the treatment of …
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<![CDATA[All Respond to BCMA/CD19 CAR T-Cell Therapy in NDMM Trials]]>
19 Dec 2025 18:59 GMT
… . Four patients received tocilizumab (Actemra) for CRS. Notably, no … Hospital of the Naval Medical University in China.
How … end point in both trials. Secondary end points included … respectively.
The most common treatment-emergent adverse effects in the …
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<![CDATA[FDA Awards National Priority Voucher to Teclistamab Plus Daratumumab in R/R Myeloma]]>
15 Dec 2025 21:33 GMT
… a large unmet medical need; promoting domestic drug development and manufacturing … .
Regarding safety, any-grade treatment-emergent adverse effects (TEAEs) … prophylactic tocilizumab (Actemra) was given, per trial protocol.
References
FDA proactively awards …
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<![CDATA[Epcoritamab Plus R-mini-CHOP May Aid in Treatment of Elderly Patients with First-Line DLBCL]]>
07 Dec 2025 03:13 GMT
… phase 2 EPCORE DLBCL-3 trial (NCT05660967 ) indicated that single-agent … were treated with either tocilizumab (Actemra; 29%) or corticosteroids (14%), leading … announces data from multiple clinical trials showing treatment with fixed-duration epcoritamab …
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<![CDATA[Newly Approved Specialty Drugs Advance Care for Inflammatory and Autoimmune Diseases]]>
20 Nov 2025 05:21 GMT
… 2024 were specialty drugs.1 As medication experts, pharmacists … treatments are beremagene geperpavec-svdt (Vyjuvek; Krystal Biotech), … pemphigoid. In clinical trials, treatment with dupilumab resulted in … to access specialty pharmaceuticals in the safest, …
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<![CDATA[Behind the FDA’s Elimination of REMS Program for CAR T-Cell Therapies]]>
11 Nov 2025 23:21 GMT
… pharmacy and treatment centers to hold a drug called tocilizumab [Actemra] onsite so … reporting of toxicities to the FDA should they occur after CAR … administration of these treatments…. Initially, we interfaced with the FDA through its …
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Roche shares fall as new drug sales disappoint
23 Oct 2025 09:37 GMT
… cancer drug Rituxan and anti-inflammatory Actemra offset shortfalls … treatments as well as heavy investments in experimental obesity drugs … 4 billion francs.
Pharmaceutical division sales for the … biotech unit Genentech plans to offer influenza antiviral pill …
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<![CDATA[Real-World Studies Reinforce Axi-Cel and Liso-Cel as Effective LBCL Treatments ]]>
23 Oct 2025 03:23 GMT
… FDA approvals of axi-cel and liso-cel affected the LBCL treatment … phase 3 ZUMA-7 trial [NCT03391466] population with … received treatment for these complications, including tocilizumab [Actemra], steroids … in the [clinical trials]. The median duration …