The FDA has said it needs more time to review Moderna's application for emergency use of its COVID-19 vaccine mRNA-1273 in children aged 12 to 17, as it looks at data on heart inflammation
A phase 1 trial of Allogene's of-the-shelf CAR-T for lymphoma has been placed on hold by the FDA, after a "chromosomal abnormality" was seen in a patient receiving the cell therapy.
Japanese drugmaker Takeda has suspended dosing in phase 2 trials of its orexin agonist TAK-994, saying it had encountered a "safety signal" in the study.
There has been a fourth patient fatality in Astellas' clinical trial of its AT132 gene therapy for the rare disease X-linked myotubular myopathy (XLMTM), which has been halted twice due to
BioMarin Pharma has had another setback in its gene therapy development programme, announcing this morning that the FDA has placed a phase 1/2 trial of its candidate for phenylketonuria (PK
The FDA has concluded its safety review of Pfizer's JAK inhibitor Xeljanz and Xeljanz XR, requiring revised warnings for the drugs as well as others in the class after finding evidence of e