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RSS FeedPosted by Michael Wonder on 25 Feb 2026
Larimar Therapeutics announces FDA breakthrough therapy designation for nomlabofusp in FA and reiterates planned BLA submission in June 2026
24 February 2026 - Larimar Therapeutics today announced the US FDA has granted breakthrough therapy designation to nomlabofusp, a frataxin protein ...
Posted by Michael Wonder on 23 Feb 2026
US FDA grants Reunion Neuroscience’s luvesilocin (RE104) breakthrough therapy designation status
23 February 2026 - Reunion Neuroscience today announced that the US FDA has granted breakthrough therapy designation to luvesilocin (formerly ...
Posted by Michael Wonder on 18 Feb 2026
Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) receives US FDA breakthrough therapy designation for patients with advanced head and neck cancer
18 February 2026 - Johnson & Johnson today announced that the US FDA has granted breakthrough therapy designation for subcutaneous amivantamab ...
Posted by Michael Wonder on 09 Feb 2026
Sanofi’s rilzabrutinib designated breakthrough therapy in the US and orphan drug in Japan for the treatment of warm autoimmune haemolytic anaemia
9 February 2026 - The US FDA has granted a designation as breakthrough therapy to Wayrilz (rilzabrutinib), a novel oral, ...
Posted by Michael Wonder on 03 Feb 2026
Relay Therapeutics announces zovegalisib granted breakthrough therapy designation by US FDA for PIK3CA mutant, HR+/HER2- advanced breast cancer
3 February 2026 - Designation supported by robust clinical data from ReDiscover trial with 600mg BID fasted and 400mg BID fed ...
Posted by Michael Wonder on 28 Jan 2026
Immix Biopharma receives US FDA breakthrough therapy designation for NXC-201
28 January 2026 - Breakthrough therapy designation granted to NXC-201 based on positive NEXICART-2 Phase 2 interim clinical results, presented at ...
Posted by Michael Wonder on 28 Jan 2026
Biogen’s litifilimab receives FDA breakthrough therapy designation for cutaneous lupus erythematosus, a disease with no targeted treatment options
28 January 2026 - Designation is based on the breadth of available litifilimab data, including the Phase 2 LILAC study result ...
Posted by Michael Wonder on 26 Jan 2026
Cogent Biosciences announces breakthrough therapy designation for bezuclastinib in combination with sunitinib for patients with gastro-intestinal stromal tumours
26 January 2026 - Cogent will submit the PEAK new drug application under previously announced RTOR designation; on track to complete ...
Posted by Michael Wonder on 21 Jan 2026
US FDA grants to Wugen’s WU-CART-007 breakthrough therapy designation for treatment of relapsed or refractory T cell acute lymphoblastic leukaemia / T cell lymphoblastic lymphoma
21 January 2026 - Wugen today announced that it has received breakthrough therapy designation from the US FDA for its ...
Posted by Michael Wonder on 20 Jan 2026
Lilly's sofetabart mipitecan receives US FDA's breakthrough therapy designation for the treatment of certain patients with platinum-resistant ovarian cancer
20 January 2025 - Eli Lilly and Company today announced that the US FDA has granted breakthrough therapy designation to sofetabart ...
Posted by Michael Wonder on 17 Jan 2026
Novartis ianalumab receives FDA breakthrough therapy designation for Sjögren’s disease
16 January 2026 - Novartis today announced that the US FDA has granted breakthrough therapy designation to ianalumab for Sjögren’s disease, ...
Posted by Michael Wonder on 14 Jan 2026
US FDA grants Ipsen’s IPN60340 (ICT01) breakthrough therapy designation in first line unfit acute myeloid leukaemia
13 January 2025 - Ipsen announced today that the US FDA has granted breakthrough therapy designation for IPN60340 in combination with ...
Posted by Michael Wonder on 12 Jan 2026
Encoded Therapeutics announces US FDA breakthrough therapy designation granted to ETX101 for the treatment of Dravet syndrome
12 January 2026 - Encoded Therapeutics today announced that the US FDA has granted breakthrough therapy designation to ETX101 for the ...
Posted by Michael Wonder on 09 Jan 2026
Revolution Medicines announces FDA breakthrough therapy designation for zoldonrasib
8 January 2026 - First breakthrough therapy designation for an investigational drug specifically targeting KRAS G12D mutation in non-small cell lung ...
Posted by Michael Wonder on 06 Jan 2026
Oculis announces US FDA breakthrough therapy designation granted to privosegtor for treatment of optic neuritis
6 January 2026 - Oculis today announced that its neuroprotective candidate privosegtor was granted breakthrough therapy designation by the US FDA ...