16 December 2024 - Designation based on data showing no evidence of disease in 100% of all 42 patients who completed ...
17 December 2024 - Gilead Sciences today announced that the US FDA has granted breakthrough therapy designation to Trodelvy (sacituzumab ...
13 December 2024 - Designation is based on positive results from the HERCULES study in adults with non-relapsing secondary progressive multiple ...
4 December 2024 - Supported by evidence from clinical studies that indicate that zorevunersen may demonstrate substantial improvement over available therapies. ...
4 December 2024 - Breakthrough therapy designation supported by results from a Phase 2 dose-ranging trial. ...
12 December 2024 - Phase 3 ECLIPSE registrational program in chronic hepatitis delta to begin in the first half of 2025. ...
9 December 2024 - Designation based on encouraging Phase 1b clinical data, including that SER-155 resulted in a 77% relative risk ...
9 December 2024 - First breakthrough therapy designation for Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan based on TROPION-Lung05 Phase 2 ...
3 December 2024 - First breakthrough therapy designation for investigational sac-TMT in the US. ...
18 November 2024 - Huahui Health today announced that its investigational hepatitis D and B drug candidate, Libevitug (HH-003), an ...
11 November 2024 - The breakthrough therapy designation for investigational nipocalimab in Sjögren’s disease, a prevalent autoantibody disease with no approved ...
10 October 2024 - Designation based on positive interim analysis of Phase 2b VANTAGE study. ...
9 October 2024 - Designation is based on data from the clinical development program which demonstrated clinical proof of concept. ...
8 October 2024 - The US FDA breakthrough therapy designation is for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis ...
7 October 2024 - Ultragenyx today announced that it has received breakthrough therapy designation from the US FDA for setrusumab (UX143) ...