MEOBF - TG Therapeutics Umbralisib Development And Other News: The Good Bad And Ugly Of Biopharma
TG Therapeutics reports development for Umbralisib
TG Therapeutics Inc. (TGTX) reported that the FDA has accepted its New Drug Application for umbralisib. The drug candidate will be reviewed under the Priority Review pathway. It had been granted Breakthrough Therapy tag for treating marginal zone lymphoma condition. Its Prescription Drug User Fee Act (PDUFA) goal date has been set at February 15, 2021. For follicular lymphoma, the drug candidate will undergo standard review and the PDUFA goal date of June 15, 2021, has been set.
TG Therapeutics has used data from the umbralisib monotherapy