FDA push­es back a re­view date for TG's 'U2' com­bo as the biotech steels it­self for up­com­ing ad­comm

The FDA has pushed back its re­view of TG Ther­a­peu­tics’ U2 com­bo (ubli­tux­imab plus Ukoniq) in pa­tients with chron­ic lym­pho­cyt­ic leukemia and small lym­pho­cyt­ic lym­phoma af­ter the drug­mak­er sub­mit­ted up­dat­ed sur­vival da­ta in Feb­ru­ary the agency deemed a ma­jor amend­ment to its ap­pli­ca­tion, ac­cord­ing to a re­lease.

The agency set a new re­view date of June 25, TG said.

The news wasn’t un­ex­pect­ed giv­en some of TG’s re­cent com­ments. In a state­ment, CEO Michael Weiss had this to say:

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.