The FDA has accepted the resubmission of the BLA for odronextamab, a CD20xCD3 bispecific antibody, for the treatment of R/R FL.1 This decision follows the achievement of an FDA-mandated enrollment target for the phase 3 confirmatory trial, OLYMPIA-1 (NCT04501666), which was the sole appr...
US FDA orphan drug designation—odronextamab (REGN1979). 2020. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=623317. Accessed 10 Oct 2024. Regeneron Pharmaceuticals. Regeneron reports first quarter 2022 financial and operating results [media release]. 4 May...
近日,再鼎医药宣布KarXT(呫诺美林+曲司氯铵)用于治疗成人精神分裂症的新药上市申请(NDA)已获国家药品监督管理局(NMPA)受理。 图源:CDE官网 2024年9月,美国FDA已经批准该产品用于治疗成人精神分裂症。彼时FDA新闻稿指出,这是靶向胆碱能受体的首个抗精神病药物,也标志着数十年来首个治疗精神分裂症的新机制药物。 Ka...
Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved fully human monoclonal antibodies. This includes Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Pralu...
FDA-approved fully human monoclonal antibodies. This includes Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz® (po...
FDA Approves Treosulfan With Fludarabine for alloHSCT Conditioning in AML and MDS Bridget Hoyt January 25th 2025 Article Treosulfan plus fludarabine was approved by the FDA for children and adults with AML or MDS before allogenic hematopoietic stem cell transplantation. Latest...
our unique ability to repeatedly and consistently translate science into medicine has led to numerous FDA-approved treatments and product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye d...
原研机构 Regeneron Pharmaceuticals, Inc. 在研适应症 非在研适应症 SARS-CoV-2 S protein抑制剂 在研机构 Roche Products Ltd. 原研机构 Regeneron Pharmaceuticals, Inc. 在研适应症 新型冠状病毒感染 非在研适应症- 最高研发阶段批准上市 首次获批国家/地区 ...
technology to create a substantial proportion of all original, FDA-approved fully human monoclonal antibodies. This includes Dupixent ® (dupilumab), Libtayo ® (cemiplimab-rwlc), Praluent ® (alirocumab), Kevzara ® (sarilumab), Evkeeza ...