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 ...
5 December 2023 - Recent Phase 3 monotherapy first results demonstrated complete response rate of 75.7% at any time. ...
4 December 2023 - Breakthrough therapy designation for novel targeted releasing system based on results from on-going Phase 2b SunRISe-1 ...
27 November 2023 - Updates are supported by data from the Phase 1/2 EPCORE NHL-1 clinical trial. ...