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 ...
A patient dosed with Intellia Therapeutics’ CRISPR gene therapy has died after suffering a severe liver-associated adverse ...
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 ...
The Food and Drug Administration is adding a new warning to a gene therapy linked to two patient deaths earlier this year ...
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 ...
In an update on nex-z's phase I study, the CRISPR-Cas9 gene therapy stayed the course out to 3 years in an initial 36-person ...
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 FDA has put a clinical hold on a Tenaya Therapeutics gene therapy study | The FDA has put a clinical hold on a Tenaya ...
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 ...