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:
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