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Celltrion’s Autoimmune Disease Treatment Aptozma Receives Product Approval in Japan
22 Sep 2025 07:45 GMT
… biosimilar of the autoimmune disease treatment Actemra (active ingredient: tocilizumab), has … (CRS).
According to IQVIA, a pharmaceutical market research firm, the Japanese … the local autoimmune disease treatment and anticancer drug markets. Its flagship …
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Celltrion wins Japan approval for Actemra biosimilar
22 Sep 2025 02:30 GMT
… held by the original drug, including rheumatoid arthritis (RA … global sales of the drug reached 2.6 billion … Actemra biosimilar in Japan, offering patients a more affordable treatment … Japan, a key global pharmaceutical market,” a Celltrion official …
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AbbVie’s Rinvoq Gains Early Traction in Giant Cell Arteritis Market, Expanding Options for Rheumatologists
25 Sep 2025 15:53 GMT
… citing challenges related to Medicare coverage and out-of … older patients and obtaining Medicare coverage for older GCA … shift perceptions around Genentech’s Actemra (tocilizumab), the long- … , while also potentially shaping treatment decisions in PMR. Spherix …
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August's FDA Focus: Approvals and pipeline updates in pediatrics
04 Sep 2025 20:16 GMT
… 5, the FDA approved fremanezumab-vfrm (Ajovy; Teva Pharmaceuticals), to … alignment with its reference drug Actemra. The IL-6 receptor … The treatment was evaluated in the phase 3 ASPEN trial, which … Investigator’s Global Assessment-treatment success (IGA-TS) …
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A Month of Breakthroughs: The FDA's Oncology Decisions in August 2025
02 Sep 2025 20:48 GMT
… the ongoing shift toward precision medicine, with accelerated approvals for … the FDA-approved drug spironolactone for the treatment of glioblastoma (GBM). The trial will … biosimilar to tocilizumab (Actemra), to include the treatment of cytokine release …
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FDA news in pediatrics: August 2025
01 Sep 2025 15:14 GMT
… its recommendation for vaccination beginning at 6 … alignment with reference tocilizumab (Actemra). Tocilizumab-anoh, an … FDA approved fremanezumab-vfrm (Ajovy; Teva Pharmaceuticals) for the preventive treatment … by phase 3 SPACE trial data, which showed …
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FDA Approves Expanded Indication for Celltrion’s AVTOZMA for the Treatment of Cytokine Release Syndrome
29 Aug 2025 22:46 GMT
… announced that it obtained FDA approval expanding the indication … tocilizumab-anoh) to include treatment of cytokine release syndrome ( … reported, Celltrion obtained FDA approval for AVTOZMA in … approved for Genentech’s ACTEMRA IV. Thomas Nusbickel, …
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FDA approves Celltrion’s Actemra biosimilar Avtozma for cytokine release syndrome
22 Aug 2025 12:03 GMT
The US Food and Drug Administration (FDA) has approved Celltrion’ … referencing Actemra (tocilizumab), received approval from the FDA earlier … to infection or immunotherapy drugs more aggressively than it … needs and support treatment continuity for patients.
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Teclistamab Real-World Data and Trial Results Show Promise in R/R Multiple Myeloma
19 Aug 2025 21:00 GMT
… Medical Sciences Myeloma Center.
Real-World Use of Teclistamab
The REALiTEC trial … 6 months of treatment. Posttreatment hypogammaglobulinemia occurred … and administered tocilizumab (Actemra) if needed. Dingli … myeloma outside of clinical trials. Presented at: …
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Trispecific Antibody JNJ-5322 Shows Potential to Redefine Treatment in R/R Multiple Myeloma
19 Aug 2025 03:07 GMT
… the FDA approved teclistamab for the treatment of … of prophylactic tocilizumab [Actemra] to reduce the … trials. For example, there is a phase 2 clinical trial … #47;www.fda.gov/drugs/;resources-information-approved-drugs/fda-grants-accelerated …