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May 19, 2026
The FDA granted Orphan Drug Designation to Cullinan Therapeutics’ CLN-049 for relapsed/refractory AML. CLN-049 is in Phase 1 studies and had already received Fast Track designation.
May 14, 2026
Senti Biosciences completed enrolment in its Phase I SENTI-202 trial in relapsed or refractory AML and said recent data showed deep, MRD-negative durable complete remissions. The company plans FDA talks in the first half of 2026 on a pivotal registration programme.
May 14, 2026
The FDA approved oral decitabine and cedazuridine tablets plus venetoclax for newly diagnosed AML in patients 75 and older or those ineligible for intensive induction chemotherapy. The approval was supported by phase 1/2 ASTX727-07 data showing a 41.6% complete response rate.
May 13, 2026
Moleculin said its MIRACLE Phase 2B/3 AML trial is nearing first unblinding, with blinded CRc above 40% and CR around 30%. The first 45-subject readout is expected before June 30, 2026.
Apr 27, 2026
Kyowa Kirin and Kura Oncology started a Japanese Phase II registrational study of ziftomenib in adults with relapsed or refractory NPM1-mutated AML. Kyowa Kirin plans to seek regulatory approval in Japan after the trial.
Apr 10, 2026
Omeros reported initial nonhuman primate data for OncotoX-AML in acute myeloid leukemia. One treatment course reduced myeloid progenitor cells by up to 99% and was well tolerated.
Feb 24, 2026
Faron Pharmaceuticals announces acceptance of bexmarilimab Phase I/II data for poster presentation at BSH 2026, while launching a new Phase II BEAM-X study evaluating the drug in AML patients post-stem cell transplantation.
Feb 21, 2026
West Virginia University Cancer Institute has dosed the first patient in a phase 1/2 trial evaluating subcutaneous blinatumomab for CD19-positive mixed-phenotype acute leukemia, a rare disease with no FDA-approved therapies. The first patient achieved complete remission after one cycle.
Feb 25, 2026
The FDA approved acalabrutinib combined with venetoclax for chronic lymphocytic leukemia and small lymphocytic leukemia based on phase III trial results. Separately, Yale researchers identified CD25 protein complex as a new drug target for aggressive leukemias.
Feb 20, 2026
The FDA approved acalabrutinib plus venetoclax as the first all-oral, fixed-duration regimen for previously untreated chronic lymphocytic leukemia, based on phase III AMPLIFY trial results showing 35% reduction in disease progression or death risk versus chemoimmunotherapy.
Feb 20, 2026
The FDA has approved the combination of Venclexta (venetoclax) plus acalabrutinib as the first all-oral, fixed-duration regimen for previously untreated adults with chronic lymphocytic leukemia, based on Phase III AMPLIFY study results.
Feb 19, 2026
Faron Pharmaceuticals announces Phase II BEAM-X trial evaluating bexmarilimab plus azacitidine in MRD-positive AML patients after stem cell transplantation. The Nordic AML Group-led trial will enroll 24 patients with first results expected 12-15 months after enrollment begins in Q3 2026.
Feb 18, 2026
Moleculin Biotech announced a preliminary blinded composite complete remission rate of 40% in the first 30 subjects of its Phase 2B/3 MIRACLE trial testing Annamycin plus cytarabine for relapsed or refractory acute myeloid leukemia.
Feb 17, 2026
TuHURA Biosciences filed an IND application with the FDA for TBS-2025, a VISTA inhibiting antibody, to be studied in combination with a menin inhibitor for treating mutNPM1 relapsed/refractory Acute Myeloid Leukemia.
Feb 17, 2026
Moleculin Biotech announced the Japan Patent Office has issued a notice of allowance for a patent covering proprietary methods for reconstituting liposomal Annamycin, strengthening the company's international intellectual property position.
May 01, 2025
The FDA approved 46 novel drugs in 2025, down from 50 in 2024. Small molecules accounted for 31 approvals (67%), with oncology leading at nine approvals. Large molecules contributed 15 approvals (33%), spanning ADCs, bispecifics, and subcutaneous delivery innovations.
Jan 16, 2026
The FDA has approved Filkri (filgrastim-laha), a biosimilar to Neupogen, for cancer patients at risk of infection due to chemotherapy and other indications. The approval marks Accord BioPharma's sixth biosimilar product.
