A patient with transthyretin amyloidosis (ATTR) who received the investigational gene therapy nexiguran ziclumeran (nex-z) in ...
The patient who was hospitalized after receiving Intellia Therapeutics’ CRISPR therapy nex-z has died. | The patient who was ...
Intellia Therapeutics has acknowledged the death of the elderly patient hospitalized last week in its Phase III trial of assessing nexiguran ziclumeran (nex-z) in transthyretin amyloidosis with ...
The updated label now includes a boxed warning and a new “limitation of use" in addition to the removal of the prior ...
Intellia Therapeutics temporarily paused dosing and screening for its phase 3 Magnitude and Magnitude-2 trials of Nex-z following a patient hospitalization, according to an Oct. 27 news release. The ...
The FDA added a boxed warning to delandistrogene moxeparvovec (Elevidys) gene therapy for Duchenne muscular dystrophy and changed the indication of the drug after reports of fatal liver injury emerged ...
The approach is “very exciting,” but one expert says a lot more research is needed, especially around safety, before clinical ...
Children’s Hospital Los Angeles (CHLA) is expanding its safety protocol for patients receiving Elevidys®, the FDA-approved ...
The FDA previously placed two clinical studies on hold, including the Phase III trial in which the liver toxicity occurred. Intellia is working with experts to create a risk management program for nex ...