Merck has reported that the U.S. FDA is conducting a priority analysis on a fresh sBLA petitioning for authorization of KEYTRUDA, Merck’s anti-PD-1 treatment.
The Menarini Group,together with their fully owned subsidiary Stemline Therapeutics Inc., declared that ORSERDU® (elacestrant) has received authorisation from the European Commission.
LAPIX Therapeutics, Inc. announced U.S. FDA clearance of its IND application. The approval enables Phase 1 trials for its leader compound, LPX-TI641, aimed at treating multiple sclerosis.
Revolution Medicines, Inc. has initiated Phase 1/1b trials for RMC-9805, a covalent, oral KRAS G12D inhibitor for RAS-dependent cancers and the first patient already dosed targeting KRAS G12D mutation-driven cancers.
Cerevance announced the start of their Phase 1 trial, with the first participant dosed to evaluate the safety, tolerability, and pharmacokinetics of CVN293.
Drug Farm, currently in the clinical phase, has shared the news of the first participant in the Phase 1 clinical experiment, testing DF-003, receiving their initial dosage.
The study on Atrial Fibrillation using Abelacimab was prematurely ended by the Data Monitoring Committee due to a massive decrease in bleeding compared to a DOAC.