While several targeted therapies are approved for acute myeloid leukemia, a 2023 U.K. study found that median survival following diagnosis was only about seven months, highlighting the need not only for new therapies, but for a faster regulatory strategy. At the American Society of Hematology’s 67th annual meeting in Orlando Dec. 6, researcher Jesse Tettero presented data supporting the use of a measurable residual disease (MRD) surrogate endpoint in acute myeloid leukemia (AML) research.
Only a couple of years since the first sickle cell disease (SCD) gene therapies gained U.S. FDA approval, researchers are working to expand access for younger children, and to improve manufacturing and commercialization to reach patients faster.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: J&D, Eli Lilly, Merakris, Uniqure.
Biopharma happenings, including deals and partnerships, and other news in brief: Alexion, Alzinova, Atossa, Astrazeneca, Formycon, Jyong, MS Pharma, Neurimmune, Orano, Propanc, Replicate, Roche, Sichuan Kelun, Vycellix.
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