The target action date for the FDA decision is July 30, 2025, providing a clear timeline for potential approval and commercialization. The BLA resubmission demonstrates strong clinical support, with an overall response rate of 80% in pivotal Phase 1 and 2 trials, highlighting the ...
2 This regulatory decision represents the first approval of odronextamab in this indication. “The [European Commission] approval of [odronextamab] is a meaningful advancement for patients [in the European Union] and their physicians as a new option to treat both indolent and aggressive ...
Stay up to date on practice-changing data in community practice. Subscribe Now! FDA Approvals & Designations in Oncology: February 2025 Highlights Jordyn Sava March 4th 2025 Article Here is a look back on all the FDA happenings from the month of February 2025. ...
siRNA ADC 疾病领域得分 一眼洞穿机构专注的疾病领域 技术平台 公司药物应用最多的技术 靶点 公司最常开发的靶点 CD20抑制剂 在研适应症 非在研适应症 高级别B细胞淋巴瘤 最高研发阶段批准上市 首次获批国家/地区 首次获批日期2024-08-22 原研机构 Regeneron Pharmaceuticals, Inc. 在研适应症 非在研适应症 SARS-...
If granted approval by the FDA, odronextamab would be the first and only bispecific antibody approved in both FL and DLBCL. Odronextamab previously received an orphan drug designation (ODD) and fast track designation (FTD) by the FDA for these patient populations. The FDA has granted ...
ETMerck's Keytruda, already boasting some 40 FDA approvals, has picked up a priority review in a proposed new use.The company's filing for the drug as part of a perioperative regimen for patients with resectable locally advanced head and neck squamous cell carcinoma has been accepted for a ...