Severe adverse event (SAE) Archives

Following patient death, FDA puts Foghorn study on partial hold

Acute myelodysplastic leukemia (AML), Clinical Hold, Clinical Trials, FDA, Myelodysplastic Syndromes, Patient Deaths, R&D, Severe adverse event (SAE)

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.

May 20, 2022/by BioSpace

LogicBio cleared to continue dosing in pediatric MMA trial

Acid Disorders, Clinical Hold, Clinical Trials, FDA, Gene Mutations, Methylmalonic Acidemia (MMA), Pediatric Rare Diseases, R&D, Rare Diseases, Severe adverse event (SAE)

LogicBio Therapeutics was granted the green light to continue dosing participants in the company’s Phase I/II Sunrise trial investigating the safety of LB-001 in patients with methylmalonic acidemia (MMA), characterized by methylmalonyl-CoA mutase (MMUT) gene mutations.

May 9, 2022/by BioSpace