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News about "FDA Fast Track Designation"
Moleculin Reports Encouraging Interim Phase 2/3 Data for Annamycin in Relapsed or Refractory AML
Moleculin Biotech has reported encouraging preliminary blinded data from its pivotal Phase 2/3 MIRACLE trial, with Annamycin plus cytarabine achieving a 37 percent composite complete remission rate in relapsed or refractory acute myeloid leukaemia.
FDA Fast Track Designation | 03/08/2026 | By News Bureau
Solu Therapeutics Receives FDA Fast Track Status for STX-0712 in CMML Treatment
Solu Therapeutics receives US Food and Drug Administration (FDA) Fast Track designation for STX-0712 to treat chronic myelomonocytic leukemia (CMML), supporting accelerated development for patients with relapsed or treatment-resistant disease and limited therapeutic options.
FDA Fast Track Designation | 28/05/2026 | By News Bureau
AskBio Doses First Participant in Phase 1/2 Trial for Pompe Disease Gene Therapy
AskBio has dosed the first participant in its Phase 1/2 PROGRESS-GT LOPD trial evaluating investigational gene therapy AB-1009 for late-onset Pompe disease, advancing research into potential long-term treatment solutions for the rare genetic disorder.
FDA Fast Track Designation | 14/05/2026 | By News Bureau
Armata Pharmaceuticals Receives FDA Fast Track Designation for AP-SA02 Bacteriophage Therapy
The FDA has granted Fast Track designation to Armata’s AP-SA02 therapy for the adjunct treatment of complicated Staphylococcus aureus bacteremia caused by MSSA and MRSA infections.
FDA Fast Track Designation | 07/05/2026 | By News Bureau | 133
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