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RSS FeedPosted by Michael Wonder on 16 Oct 2025
atai Life Sciences and Beckley Psytech announce US FDA breakthrough therapy designation granted to BPL-003, underscoring its potential in treatment-resistant depression
16 October 2025 - FDA designation follows previously announced Phase 2b topline data which showed rapid and durable anti-depressant outcomes following ...
Posted by Michael Wonder on 13 Oct 2025
Bicara Therapeutics announces ficerafusp alfa granted breakthrough therapy designation by US FDA for first-line HPV negative metastatic or with unresectable, recurrent head and neck squamous cell carcinoma
13 October 2025 - Bicara Therapeutics today announced that the US FDA has granted breakthrough therapy designation to ficerafusp alfa in ...
Posted by Michael Wonder on 13 Oct 2025
BeOne Medicines’ sonrotoclax granted breakthrough therapy designation by US FDA
13 October 2025 - Breakthrough designation based on early, positive results of a Phase 1/2 study of sonrotoclax in patients with ...
Posted by Michael Wonder on 10 Oct 2025
Cidara Therapeutics receives US FDA breakthrough therapy designation for CD388 in seasonal influenza prevention
9 October 2025 - Cidara Therapeutics today announced that the US FDA has granted breakthrough therapy designation for CD388 for prevention ...
Posted by Michael Wonder on 07 Oct 2025
Spruce Biosciences receives US FDA breakthrough therapy designation for tralesinidase alfa enzyme replacement therapy in Sanfilippo syndrome type B
6 October 2025 - Breakthrough therapy designation supported by integrated long-term clinical data demonstrating normalisation in cerebral spinal fluid heparan sulphate ...
Posted by Michael Wonder on 03 Oct 2025
Nacuity Pharmaceuticals granted US FDA breakthrough therapy designation for NPI-001 (N-acetylcysteine amide) tablets for the treatment of retinitis pigmentosa
2 October 2025 - Nacuity Pharmaceuticals today announced that the US FDA has granted breakthrough therapy designation to NPI-001 (N-acetylcysteine amide) ...
Posted by Michael Wonder on 03 Oct 2025
Taysha Gene Therapies announces FDA breakthrough therapy designation and provides positive regulatory update on TSHA-102 in Rett syndrome
2 October 2025 - Breakthrough therapy designation granted based on FDA’s review of available clinical evidence of safety and efficacy from ...
Posted by Michael Wonder on 26 Sep 2025
Vertex announces key advancements across kidney portfolio
25 September 2025 - Vertex announced today that the FDA has granted breakthrough therapy designation to povetacicept for the treatment of ...
Posted by Michael Wonder on 15 Sep 2025
Raludotatug deruxtecan granted breakthrough therapy designation by US FDA for patients with CDH6 expressing platinum-resistant ovarian, primary peritoneal or fallopian tube cancers previously treated with bevacizumab
15 September 2025 - Raludotatug deruxtecan has been granted breakthrough therapy designation by the US FDA for the treatment of ...
Posted by Michael Wonder on 10 Sep 2025
Ionis receives US FDA breakthrough therapy designation for ION582 in Angelman syndrome
9 September 2025 - Pivotal Phase 3 REVEAL study enrollment on track to complete in 2026. ...
Posted 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 ...