Blog
RSS FeedPosted by Michael Wonder on 22 May 2024
Durect Corporation receives FDA breakthrough therapy designation for larsucosterol in alcohol-associated hepatitis
21 May 2024 - Durect plans to confirm the efficacy and safety of larsucosterol in a registrational Phase 3 clinical ...
Posted by Michael Wonder on 16 May 2024
Nuvalent receives US FDA breakthrough therapy designation for NVL-655
16 May 2024 - Nuvalent today announced that the US FDA has granted breakthrough therapy designation to NVL-655 for the ...
Posted by Michael Wonder on 13 May 2024
Petosemtamab granted breakthrough therapy designation by the US FDA
13 May 2023 - Merus today announced that the US FDA has granted breakthrough therapy designation for petosemtamab for the ...
Posted by Michael Wonder on 10 May 2024
Novartis receives FDA breakthrough therapy designation for Scemblix in first-line CML
10 May 2024 - Breakthrough therapy designation was granted based on positive data from the Phase 3 ASC4FIRST study, in which ...
Posted by Michael Wonder on 29 Apr 2024
Soleno Therapeutics receives breakthrough therapy designation from US FDA for diazoxide choline extended release tablets in Prader-Willi syndrome
29 April 2024 - Designation is based on data from the Phase 3 program for diazoxide choline. ...
Posted by Michael Wonder on 22 Apr 2024
Kura Oncology receives breakthrough therapy designation for ziftomenib in NPM1 mutant AML
22 April 2024 - Ziftomenib is the first investigational treatment to be granted breakthrough therapy designation for NPM1 mutant AML. ...
Posted by Michael Wonder on 07 Apr 2024
FDA grants breakthrough therapy designation to sunvozertinib for the first-line treatment of patients with advanced non-small cell lung cancer harboring EGFR exon 20 insertion mutations
7 April 2024 - Dizal today announced that the US FDA has granted breakthrough therapy designation to its sunvozertinib as ...
Posted by Michael Wonder on 14 Mar 2024
Cybin receives FDA breakthrough therapy designation for its novel psychedelic molecule CYB003
13 March 2024 - First known breakthrough therapy designation granted by the FDA for an adjunctive psychedelic based therapy for the ...
Posted by Michael Wonder on 08 Mar 2024
MindMed receives FDA breakthrough therapy designation for MM120 for generalized anxiety disorder
7 March 2024 - Mind Medicine today announced that FDA has granted breakthrough designation to its MM120 (lysergide d-tartrate) program for ...
Posted by Michael Wonder on 27 Feb 2024
Nuvalent receives US FDA breakthrough therapy designation for NVL-520
27 February 2024 - Nuvalent today announced that the US FDA has granted breakthrough therapy designation to NVL-520 for the ...
Posted by Michael Wonder on 26 Feb 2024
Bayer receives US FDA breakthrough therapy designation for BAY 2927088 for non-small-cell lung cancer harbouring HER2 activating mutations
26 February 2024 - BAY 2927088 is an oral, small molecule tyrosine kinase inhibitor under development as a potential new targeted ...
Posted by Michael Wonder on 16 Feb 2024
Sibeprenlimab received US FDA breakthrough therapy designation for the treatment of immunoglobulin A nephropathy
16 February 2024 - Otsuka and Visterra announce that the US FDA has granted breakthrough therapy designation for the investigational drug ...
Posted by Michael Wonder on 12 Feb 2024
RadioMedix and Orano Med receive FDA breakthrough therapy designation for AlphaMedix in gastro-enteropancreatic neuroendocrine tumours
12 February 2024 - First targeted alfa therapy to receive a breakthrough therapy designation. ...
Posted by Michael Wonder on 09 Feb 2024
Johnson & Johnson's nipocalimab granted US FDA breakthrough therapy designation for the treatment of individuals at high risk for severe haemolytic disease of the foetus and newborn
9 February 2024 - Breakthrough therapy designation for nipocalimab based on results from the Phase 2 UNITY clinical trial for haemolytic ...
Posted by Michael Wonder on 07 Feb 2024
FDA grants latozinemab breakthrough therapy designation for frontotemporal dementia due to a progranulin gene mutation
7 February 2024 - Latozinemab is the most advanced progranulin-elevating candidate in development for frontotemporal dementia with a progranulin gene mutation ...