29 April 2024 - Designation is based on data from the Phase 3 program for diazoxide choline. ...
22 April 2024 - Ziftomenib is the first investigational treatment to be granted breakthrough therapy designation for NPM1 mutant AML. ...
7 April 2024 - Dizal today announced that the US FDA has granted breakthrough therapy designation to its sunvozertinib as ...
13 March 2024 - First known breakthrough therapy designation granted by the FDA for an adjunctive psychedelic based therapy for the ...
7 March 2024 - Mind Medicine today announced that FDA has granted breakthrough designation to its MM120 (lysergide d-tartrate) program for ...
27 February 2024 - Nuvalent today announced that the US FDA has granted breakthrough therapy designation to NVL-520 for the ...
26 February 2024 - BAY 2927088 is an oral, small molecule tyrosine kinase inhibitor under development as a potential new targeted ...
16 February 2024 - Otsuka and Visterra announce that the US FDA has granted breakthrough therapy designation for the investigational drug ...
12 February 2024 - First targeted alfa therapy to receive a breakthrough therapy designation. ...
9 February 2024 - Breakthrough therapy designation for nipocalimab based on results from the Phase 2 UNITY clinical trial for haemolytic ...
7 February 2024 - Latozinemab is the most advanced progranulin-elevating candidate in development for frontotemporal dementia with a progranulin gene mutation ...
23 January 2024 - FDA acknowledges significant potential impact of MPAR's oral overdose protection. ...
21 December 2023 - Designation is based on Phase 1/2 safety and efficacy data in patients with HER2 expressing advanced endometrial ...
5 December 2023 - Crinecerfont new drug application submission planned in 2024. ...
5 December 2023 - The US FDA granted breakthrough therapy designation for VT-X7, Osteal Therapeutics’ investigational drug therapy for periprosthetic joint ...