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RSS FeedPosted by Michael Wonder on 04 Sep 2025
Lilly's olomorasib receives US FDA's breakthrough therapy designation for the treatment of certain newly diagnosed metastatic KRAS G12C-mutant lung cancers
4 September 2025 - The breakthrough therapy designation for olomorasib is based on data from the Phase 1/2 LOXO-RAS-20001 trial and ...
Posted by Michael Wonder on 04 Sep 2025
FDA grants Hernexeos breakthrough therapy designation for first-line use in HER2 mutant advanced NSCLC
3 September 2025 - Breakthrough therapy designation is based on results from the Beamion-LUNG 1 clinical trial evaluating Hernexeos (zongertinib tablets) ...
Posted by Michael Wonder on 28 Aug 2025
D3 Bio announces FDA breakthrough therapy designation and orphan drug designation for D3S-001 for the treatment of patients with KRAS G12C mutated cancers
28 August 2025 - D3 Bio today announced that the US FDA has granted a breakthrough therapy designation to D3S-001, the ...
Posted by Michael Wonder on 27 Aug 2025
Genmab receives FDA breakthrough therapy designation for rinatabart sesutecan in advanced endometrial cancer
t26 August 2025 - Genmab announced today that the US FDA has granted breakthrough therapy designation to rinatabart sesutecan, an investigational ...
Posted by Michael Wonder on 26 Aug 2025
Rusfertide receives breakthrough therapy designation for treatment of erythrocytosis in patients with polycythemia vera
25 August 2025 - Breakthrough therapy designation complements rusfertide's orphan drug and fast track designations, which together confer multiple benefits to ...
Posted by Michael Wonder on 20 Aug 2025
Izalontamab brengitecan (EGFRxHER3 ADC) granted breakthrough therapy designation by US FDA for patients with previously treated advanced EGFR mutated non-small cell lung cancer
18 August 2025 - First breakthrough therapy designation in the US for SystImmune and Bristol Myers Squibb’s izalontamab brengitecan based ...
Posted by Michael Wonder on 18 Aug 2025
Ifinatamab deruxtecan granted breakthrough therapy designation by US FDA for patients with pre-treated extensive stage small cell lung cancer
18 August 2025 - First breakthrough therapy designation for Daiichi Sankyo and Merck’s ifinatamab deruxtecan based on IDeate-Lung01 phase 2 ...
Posted by Michael Wonder on 04 Aug 2025
Dyne Therapeutics announces FDA breakthrough therapy designation for DYNE-251 in Duchenne muscular dystrophy
4 August 2025 - Dyne Therapeutics today announced that the US FDA has granted breakthrough therapy designation to DYNE-251 for ...
Posted by Michael Wonder on 28 Jul 2025
Imfinzi granted priority review and breakthrough therapy designation in the US for patients with resectable early-stage gastric and gastro-oesophageal junction cancers
28 July 2025 - Based on MATTERHORN Phase 3 trial results which demonstrated a statistically significant and clinically meaningful event-free survival ...
Posted by Michael Wonder on 24 Jul 2025
Avidity Biosciences receives FDA breakthrough therapy designation for delpacibart zotadirsen for the treatment of DMD in people with mutations amenable to exon 44 skipping
23 July 2025 - On track for planned BLA submission for delpacibart zotadirsen at year end 2025. ...
Posted by Michael Wonder on 24 Jul 2025
Revolution Medicines announces FDA breakthrough therapy designation for elironrasib
23 July 2025 - Designation based on encouraging clinical data observed with elironrasib in patients with advanced KRAS G12C non-small ...
Posted by Michael Wonder on 18 Jul 2025
Praxis Precision Medicines receives FDA breakthrough therapy designation for relutrigine for the treatment of seizures associated with SCN2A and SCN8A developmental and epileptic encephalopathies
17July 2025 - The breakthrough therapy designation was granted based on the highly compelling results from the Phase 2 EMBOLD trial ...
Posted by Michael Wonder on 17 Jul 2025
Enhertu plus pertuzumab granted breakthrough therapy designation in the US as first-line therapy for patients with HER2 positive metastatic breast cancer
17 July 2025 - Ninth breakthrough therapy designation for Daiichi Sankyo and AstraZeneca’s Enhertu with the latest based on DESTINY-Breast09 ...
Posted by Michael Wonder on 15 Jul 2025
Egetis receives FDA breakthrough therapy designation for tiratricol for MCT8 deficiency
15 July 2025 - Egetis Therapeutics today announced that the US FDA has granted breakthrough therapy designation for tiratricol, as ...
Posted by Michael Wonder on 11 Jul 2025
Transcend Therapeutics receives breakthrough therapy designation for TSND- 201 (methylone) for the treatment of PTSD
10 July 2025 - Company planning to initiate Phase 3 program. ...