The U.S. Food and Drug Administration issued a partial clinical hold for Foghorn Therapeutics’ Phase I clinical study, investigating the safety and efficacy of FHD-286 in patients with relapsed and/or refractory acute myelodysplastic leukemia (AML) and myelodysplastic syndromes (MDS). The hold follows a serious adverse event in which a study participant died after developing possible differentiation syndrome.
Almost three times as many people have died as a result of COVID-19 as official data show, according to a new World Health Organization (WHO) report, the most comprehensive look at the true global toll of the pandemic so far.
Shares of Taysha Gene Therapies were down more than 10 percent after a patient’s death marred positive interim data for the company’s experimental gene therapy treatment for Sandhoff and Tay-Sachs diseases, which are two forms of GM2 gangliosidosis.
Shares of Kura Oncology plunged in trading on November 24 after the San Diego-based company announced the U.S. Food and Drug Administration placed a partial clinical hold on a Phase Ib leukemia study assessing KO-539 following the report of a patient’s death.
A patient treated with Astellas Pharma’s experimental gene therapy for patients with X-linked Myotubular Myopathy (XLMTM) died after reports of a serious adverse event following treatment with AT132.
Cellectis announced that the U.S. Food and Drug Administration placed a clinical hold on the company’s MELANI-01 trial of UCARTCS1A for relapsed or refractory multiple myeloma (MM).
