Fast track designation has been granted by the FDA to Deltacel with low-dose radiation for pretreated metastatic non–small cell lung cancer.
近日,百吉生物收到美国FDA正式书面回函,其第四条全球独家首创产品管线BST02注射液被授予“快速通道资格”(Fast Track Designation, FTD),用于治疗所有类型的肝癌(包括肝细胞癌和胆管癌)。 FTD快速通道资格的设立旨在促进或加速用于治疗严重或危及生命的疾病,且显示出有潜力满足当前未满足临床需求的药物开发,使药物能够快...
The fast track designation will expedite the clinical development of the asset for melanoma treatment. Credit: yanishevska/Shutterstock. The US Food and Drug Administration (FDA) has granted its fast track designation toInnovent Biologics‘ IBI363, a PD-1/IL-2α-biasbispecific antibody fusion prot...
Tamibarotene plus azacitidine and venetoclax has received FDA fast track designation for newly diagnosed, unfit, RARA-overexpressed AML. FDA The FDA has granted fast track designation to tamibarotene in combination with azacitidine (Vidaza) and venetoclax (Venclexta) for the ...
ICT01 plus azacitidine and venetoclax has received fast track designation from the FDA in patients with untreated AML unfit for induction chemotherapy.
VMT01 has been granted a fast track designation from the FDA for the treatment of MC1R-expressing unresectable or metastatic melanoma.1 Fast track designation is intended to expedite the development and review of agents that treat serious conditions and fill unmet medical needs. With this designatio...
"We are thrilled to receive Fast Track designation from the FDA for intranasal foralumab for the treatment of Multiple Sclerosis," said Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences. "This designation underscores the potential of foralumab to address critical unmet ne...
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BNT324/DB-1311 gained fast track designation from the FDA in unresectable advanced or metastatic castration-resistant prostate cancer who have progressed after standard treatments. The FDA has granted a fast track designation to BNT324/DB-1311, an antibody-drug conjugate (ADC), for the treatment ...
Fast track designation is awarded to new drugs and vaccines that are intended to treat or prevent serious conditions and have the potential to address an unmet medical need. With this designation, the development process for SYNC-T SV-102 can benefit from more frequent engagement with the FDA,...