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RSS FeedPosted by Michael Wonder on 14 Jan 2025
Adaptimmune announces US FDA breakthrough therapy designation granted to letetresgene autoleucel for treatment of myxoid/round cell liposarcoma
13 January 2025 - Adaptimmune Therapeutics today announced that letetresgene autoleucel has been granted breakthrough therapy designation by the US ...
Posted by Michael Wonder on 09 Jan 2025
Denali Therapeutics announces US FDA breakthrough therapy designation granted to tividenofusp alfa for the treatment of Hunter syndrome
8 January 2025 - Denali Therapeutics today announced that the US FDA has granted breakthrough therapy designation for tividenofusp alfa (DNL310) ...
Posted by Michael Wonder on 08 Jan 2025
Rezolute receives breakthrough therapy designation from FDA for ersodetug in the treatment of hypoglycaemia due to congenital hyperinsulinism
7 January 2025 - Breakthrough therapy designation granted based on key positive data from the Phase 2b (RIZE) study and current ...
Posted by Michael Wonder on 07 Jan 2025
GSK’s B7-H3 targeted antibody drug conjugate, GSK’227, receives US FDA breakthrough therapy designation in late-line relapsed or refractory osteosarcoma
7 January 2025 - Regulatory designation based on promising early data in this rare bone cancer. ...
Posted by Michael Wonder on 18 Dec 2024
Jemperli (dostarlimab) receives US FDA breakthrough therapy designation for locally advanced dMMR/MSI-H rectal cancer
16 December 2024 - Designation based on data showing no evidence of disease in 100% of all 42 patients who completed ...
Posted by Michael Wonder on 17 Dec 2024
US FDA grants breakthrough therapy designation to Trodelvy (sacituzumab govitecan-hziy) for second-line treatment of extensive-stage small cell lung cancer
17 December 2024 - Gilead Sciences today announced that the US FDA has granted breakthrough therapy designation to Trodelvy (sacituzumab ...
Posted by Michael Wonder on 13 Dec 2024
Tolebrutinib designated breakthrough therapy by the FDA for non-relapsing secondary progressive multiple sclerosis
13 December 2024 - Designation is based on positive results from the HERCULES study in adults with non-relapsing secondary progressive multiple ...
Posted by Michael Wonder on 13 Dec 2024
Stoke Therapeutics receives FDA breakthrough therapy designation for zorevunersen for the treatment of Dravet syndrome
4 December 2024 - Supported by evidence from clinical studies that indicate that zorevunersen may demonstrate substantial improvement over available therapies. ...
Posted by Michael Wonder on 13 Dec 2024
Allay Therapeutics receives FDA breakthrough therapy designation for ATX101 for the treatment of post-surgical pain following total knee replacement surgery
4 December 2024 - Breakthrough therapy designation supported by results from a Phase 2 dose-ranging trial. ...
Posted by Michael Wonder on 13 Dec 2024
Vir Biotechnology receives FDA breakthrough therapy designation and EMA PRIME designation for tobevibart and elebsiran in chronic hepatitis delta
12 December 2024 - Phase 3 ECLIPSE registrational program in chronic hepatitis delta to begin in the first half of 2025. ...
Posted by Michael Wonder on 10 Dec 2024
FDA grants breakthrough therapy designation to Seres Therapeutics’ SER-155 for reduction of bloodstream infections in adults undergoing allogeneic haematopoietic stem cell transplantation
9 December 2024 - Designation based on encouraging Phase 1b clinical data, including that SER-155 resulted in a 77% relative risk ...
Posted by Michael Wonder on 10 Dec 2024
Datopotamab deruxtecan granted breakthrough therapy designation in US for patients with previously treated advanced EGFR mutated non-small cell lung cancer
9 December 2024 - First breakthrough therapy designation for Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan based on TROPION-Lung05 Phase 2 ...
Posted by Michael Wonder on 06 Dec 2024
FDA grants breakthrough therapy designation to sacituzumab tirumotecan for the treatment of certain patients with previously treated advanced or metastatic non-squamous non-small cell lung cancer with EGFR mutations
3 December 2024 - First breakthrough therapy designation for investigational sac-TMT in the US. ...
Posted by Michael Wonder on 19 Nov 2024
FDA grants breakthrough therapy designation to Huahui Health's libevitug (HH-003) for treatment of chronic hepatitis D virus infection
18 November 2024 - Huahui Health today announced that its investigational hepatitis D and B drug candidate, Libevitug (HH-003), an ...
Posted by Michael Wonder on 12 Nov 2024
Nipocalimab is the first and only investigational therapy granted US FDA breakthrough therapy designation for the treatment of adults living with moderate to severe Sjögren’s disease
11 November 2024 - The breakthrough therapy designation for investigational nipocalimab in Sjögren’s disease, a prevalent autoantibody disease with no approved ...