ADC Drug Trade name Maker Disease Indication Payload/Payload Class Payload Action Target mAb Linker DAR Approval Year Mirvetuximab soravtansine ELAHERE ImmunoGen Platinum-Resistant Ovarian Cancer Maytansinoid DM4 Folate receptor alpha FRα IgG1 / N/A 2022 Tisotumab vedotin-tftv Tivdak Seagen Inc...
近年来,罕见病药物的收入已经成为MNC收入结构的重要成分,BMS 2022年含有罕见病适应症的药物营收达到213亿美元,占公司全球销售额的45%。福泰制药几乎100%的营收来自囊性纤维化领域,年销售额近100美元,可见罕见病药物市场也是星辰大海。 参考资料 美国孤儿药资格认定及批准上市情况分析。 2023 drug approvals: After a ...
With the first quarter of 2022 now in the rearview mirror, the FDA has approved 10 new drugs (TABLE 1), 4 short of the total this time last year. The decline might add fuel to speculation that the agency is showing more rigour around authorizations following the controversy surrounding ...
A comprehensive list of the US FDA’s Center for Drug Evaluation & Research (CDER)'s new drug therapy approvals for 2022. CDER approved 37 new drugs in 2022, down from50 in 2021, either as new molecular entities (NMEs) under New Drug Applications (NDAs), or as new therapeutic biologics...
1.U.S. Food & Drug Administration. Novel Drug Approvals for 2024. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2024 2.2024年美国FDA都批准了哪些新药? https://mp.weixin.qq.com/s/aMEtOOZMAlMag6qSfBoHFw
作者: 2022🇺🇸FDA New drug Approvals
Approval was based on the PSOARING clinical trials, which compared use versus topical placebo. Approximately 35-40% of patients who received active drug had clear or almost clear scores after 12 weeks, as compared to 6% of patients on placebo.N Engl J Med 2021;385:2219-2229 ...
Approval was based on the Phase 2 DeLLphi-301 study (N = 99). Patients received an initial 1-mg dose followed by 10 mg on Days 8, 15, and every 2 weeks thereafter until disease progression or unacceptable toxicity. Overall response rate (ORR) was 40% (complete response 2% and partial...
Approval in March 2022 was based on the RELATIVITY-047 phase 2/3 global trial, which found a median progression-free survival (PFS) of 10.1 months in 355 patients randomly assigned to the combination therapy, compared to 4.6 months in 359 patients who received nivolumab alone (HR, 0.75;P=0....
(and higher than historical norms),demonstrating that innovation remains strong in the drug development sector.CD 27、ER only approves drug and biologic appli-cations that meet our high regulatory standards.CDERs novel drug approvals for 2022 are listed alphabetically below by trade name.*Trade ...