-
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) …
-
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 …
-
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 …
-
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, …
-
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.
-
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: …
-
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 …
-
FDA Expands Avtozma to Include Cytokine Release Syndrome Treatment for Adults and Children
12 Aug 2025 11:43 GMT
… FDA-approved indications of its biosimilar, Actemra.
This approval is an additional treatment … cells in one trial and 76% in another … phase III clinical trials demonstrating the drug’s efficacy, … providing an FDA-approved, biosimilar treatment option for both …
-
FDA Approves Expanded Indication for Celltrion’s AVTOZMA
11 Aug 2025 12:53 GMT
… U.S. Food and Drug Administration (FDA) has approved an expanded … -anoh) to include the treatment of cytokine release syndrome (CRS … all indications approved for ACTEMRA IV in the United … indication alignment with the reference ACTEMRA IV. This milestone marks …
-
FDA Grants Approval to Celltrion for Expanded Indication of Actemra Biosimilar to Treat CRS
09 Aug 2025 03:22 GMT
… IV) therapy, to include the treatment of cytokine release syndrome (CRS … COVID-19. Multiple myeloma drugs that may cause CRS include … global Phase III clinical trial designed to evaluate the … Aug. 7, 2025.
2. FDA. Actemra Approval Letter. fda.gov, Jan. 8, 2010 …