FDA clearance
Biomea Fusion to Study FLT3 Inhibitor in Phase I Leukemia Trial
The FDA cleared the firm's IND to study BMF-500 in refractory acute myeloid leukemia patients with FLT3-wild type, FTL3-mutated, and MLL4/NPM1-mutated cancers.
Bridge Biotherapeutics Starting Phase I/II Trial of Fourth-Generation EGFR TKI in NSCLC
The FDA cleared the firm's IND to evaluate BBT-207 among EGFR-mutated lung cancer patients resistant to earlier-generation EGFR inhibitors.
Tango Therapeutics to Start Phase I/II Trial of TNG260 in STK11-Mutant Cancers
The firm will evaluate the investigational CoREST complex inhibitor with Merck's Keytruda as a treatment for advanced STK11-mutant tumors, including NSCLC.
Biocartis Nabs FDA 510(k) Clearance for Lynch Syndrome Screening Assay
The Idylla MSI Test identifies microsatellite instability in colorectal cancer tumors to aid in the identification of potential Lynch syndrome.
Exelixis, Sairopa to Begin Phase I Trial of ADU-1805 in Advanced Solid Tumors
Beyond evaluating ADU-1805's safety and pharmacokinetics, the firms will assess biomarkers modulated when the monoclonal antibody binds to SIRPα.