FDA Comment 1: Develop and validate a product-specific host cell protein(HCP)assay that has improved sensitivity and capability to detect a greater range of potential HCPs compared to the current assay and to implement this assay for drug substance r...
” Yong (Ben) Ben, MD, chief medical officer, Immuno-Oncology, at BeiGene, Ltd. “…This BLA acceptance brings us closer to potentially providing tislelizumab as a treatment
药物背景：如果获得批准，odronextamab将成为第一个也是唯一一个在FL和DLBCL（非霍奇金淋巴瘤的两种最常见亚型）中获得批准的双特异性抗体。Ref.1.Checkpoint Therapeutics Announces FDA Filing Acceptance of Biologics License Application for Cosibelimab in Metastatic or Locally Advanced Cutaneous Squamous Cell Ca...
3.https://www.prnewswire.com/news-releases/citius-pharmaceuticals-announces-fda-acceptance-of-the-bla-resubmission-of-lymphir-denileukin-diftitox-for-the-treatment-of-adults-with-relapsed-or-refractory-cutaneous-t-cell-lymphoma-302090911.ht...
Acceptance follows resolution of third-party fill/finish manufacturing issues FDA decision expected by July 10, 2025 TARRYTOWN, N.Y., Feb. 11, 2025 ...
[1] ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological ...
sufficient for purposes of potential approval of the resubmitted BLA for linvoseltamab in R/R multiple myeloma by the U.S. Food and Drug Administration; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products and Regeneron’s Product Candida...
Regeneron announced FDA acceptance of odronextamab's BLA for relapsed/refractory follicular lymphoma, decision expected by July 30, 2025.
参考来源:‘Abeona Therapeutics Announces FDA Acceptance of BLA Resubmission of Pz-cel for the Treatment of Recessive Dystrophic Epidermolysis Bullosa. News Release. Abeona Therapeutics. November 12, 2024. Accessed November 12, 2024.’注:本文旨在介绍医药健康研究,不作任何用药依据,具体用药指引,请咨询主治...
11.Akebia Receives FDA Acceptance of Resubmission to NDA of Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease.PR Newswire.25.10.2023. 12.CRISPR Therapeutics Announces Completion of FDA Advisory Committee Meeting for Exagamglogene A...