TG Therapeutics, Inc.
NEWS
Since its inception in 1992, the FDA’s accelerated approval pathway has helped shepherd nearly 300 new drugs to the market. However, recent years have seen a number of high-profile market withdrawals and failed confirmatory trials.
89bio presented positive data for pegozafermin in SHTG, Tonix enrolled its first patient with Long COVID for TNX-102, Belite enrolled patients with STGD1 and more clinical trial news.
TG Therapeutics announced the publication of Phase III trials of relapsing/remitting multiple sclerosis (RMS) drug candidate in the NEJM.
BMS, TG Therapeutics, Spero and Merck are all preparing for PDUFA dates over the next couple of weeks. Here’s a closer look.
Shares of TG Therapeutics are falling fast in Wednesday trading after the U.S. Food and Drug Administration announced it was pulling approval of the cancer drug Ukoniq (umbralisib).
The FDA has decided to extend the Prescription Drug User Fee Act (PDUFA) review date for TG Therapeutics’s ublituximab until December 2022.
Toxicities and concerning patient survival data sparked a U.S. Food and Drug Administration advisory committee to recommend shutting the door on single-arm clinical studies of PI3K inhibitors.
The U.S. FDA’s Oncologic Drugs Advisory Committee is holding a meeting on April 21, 2022, to discuss safety findings across the entire class of PI3K inhibitors for hematological cancers.
TG Therapeutics voluntarily withdrew its pending BLA and supplemental NDA for its treatment dubbed U2 for adults with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
JOBS
IN THE PRESS