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RSS FeedPosted 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 ...
Posted by Michael Wonder on 23 Jan 2024
Ensysce Biosciences announces FDA breakthrough therapy designation granted for PF614-MPAR
23 January 2024 - FDA acknowledges significant potential impact of MPAR's oral overdose protection. ...
Posted by Michael Wonder on 22 Dec 2023
BioNTech and DualityBio receive FDA breakthrough therapy designation for antibody drug conjugate candidate BNT323/DB-1303 in endometrial cancer
21 December 2023 - Designation is based on Phase 1/2 safety and efficacy data in patients with HER2 expressing advanced endometrial ...
Posted by Michael Wonder on 06 Dec 2023
Neurocrine Biosciences receives breakthrough therapy designation from US FDA for crinecerfont in congenital adrenal hyperplasia
5 December 2023 - Crinecerfont new drug application submission planned in 2024. ...
Posted by Michael Wonder on 05 Dec 2023
Osteal Therapeutics’ VT-X7 receives FDA’s breakthrough therapy designation for the treatment of periprosthetic joint infection of the hip and knee
5 December 2023 - The US FDA granted breakthrough therapy designation for VT-X7, Osteal Therapeutics’ investigational drug therapy for periprosthetic joint ...
Posted by Michael Wonder on 05 Dec 2023
CG Oncology receives both FDA fast track and breakthrough therapy designation for cretostimogene grenadenorepvec in high risk BCG unresponsive non-muscle invasive bladder cancer
5 December 2023 - Recent Phase 3 monotherapy first results demonstrated complete response rate of 75.7% at any time. ...
Posted by Michael Wonder on 05 Dec 2023
Johnson & Johnson's investigational TAR-200 granted US FDA breakthrough therapy designation for the treatment of high risk non-muscle invasive bladder cancer
4 December 2023 - Breakthrough therapy designation for novel targeted releasing system based on results from on-going Phase 2b SunRISe-1 ...
Posted by Michael Wonder on 27 Nov 2023
AbbVie announces US FDA and EMA updates for epcoritamab (Epkinly/Tepkinly) for the treatment of relapsed/refractory follicular lymphoma
27 November 2023 - Updates are supported by data from the Phase 1/2 EPCORE NHL-1 clinical trial. ...
Posted by Michael Wonder on 17 Nov 2023
Palvella Therapeutics announces US FDA breakthrough therapy designation granted to Qtorin 3.9% rapamycin anhydrous gel (Qtorin rapamycin) for the treatment of microcystic lymphatic malformations
16 November 2023 - Qtorin rapamycin has potential to be first approved therapy and standard of care in the US for ...
Posted by Michael Wonder on 02 Nov 2023
Nectero Medical granted breakthrough therapy designation for the Nectero EAST system to treat infrarenal AAA
1 November 2023 - Phase 2/3 clinical trial to initiate enrolment in Q4, 2023. ...