The FDA has granted fast track designation to tamibarotene in combination with azacitidine (Vidaza) and venetoclax (Venclexta) for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) harboring RARA gene overexpression, as detected by an FDA-approved tes...
Fast track designation has been granted by the FDA to Deltacel with low-dose radiation for pretreated metastatic non–small cell lung cancer.
“The growing body of data on ICT01 together with the FDA’s fast track designation further validates our development of ICT01 in [patients with] first-line AML and highlights the critical need for therapies that generate higher response ...
The FDA has granted Fast Track Designation to avutometinib, an investigational RAF/MEK clamp, in combination with the KRAS G12C inhibitor sotorasib (Lumakras; Amgen Inc.) for the treatment of patients with KRAS G12C-mutant metastatic non-small cell lung cancer (NSCLC) who...
The combination of botensilimab and balstilimab is moving down the FDA pipeline and may become an approved treatment for non-microsatellite instability-high and deficient mismatch repair metastatic colorectal cancer in the future. The FDA has granted a fast track designation to th...
1. RemeGen’s RC88 obtained FDA fast track designation, heralds new hope for ovarian cancer patients. News release. RemeGen. January 12, 2024. Accessed January 12, 2024. http://tinyurl.com/5h47am5h 2. RC88 in platinum-resistant recurrent epithelial ovaria...
SynKIR-110, which received fast track designation from the FDA, is currently under investigation as treatment for patients with mesothelioma in the phase 1 STAR-101 trial. The FDA has granted fast track designation to the investigational agent SynKIR-110 for the treatment of patients wi...
The FDA has granted fast track designation for intranasal administration of a fully human anti-CD3 monoclonal antibody to treat non-active, secondary-progressive multiple sclerosis, according to the manufacturer. Tiziana Life Sciences said in a press rel
/PRNewswire/ -- Aspen Neuroscience today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for ANPD001 for the...