MedPage Today on MSN
Trial Patient Dies After Receiving CRISPR Gene Therapy
A patient with transthyretin amyloidosis (ATTR) who received the investigational gene therapy nexiguran ziclumeran (nex-z) in ...
BioSpace
Patient Dies After Receiving Intellia’s CRISPR Gene Therapy Candidate
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 ...
GEN - Genetic Engineering and Biotechnology News
Patient Dies After Treatment with Intellia CRISPR Therapy in Phase III Trial
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 ...
Fierce Pharma
FDA restricts Sarepta's gene therapy Elevidys after Duchenne patient deaths
The updated label now includes a boxed warning and a new “limitation of use" in addition to the removal of the prior ...
FDA adds strongest warning to Sarepta gene therapy linked to 2 patient deaths
The Food and Drug Administration is adding a new warning to a gene therapy linked to two patient deaths earlier this year ...
US FDA adds strongest warning to Sarepta's Elevidys after fatal liver injuries
The U.S. Food and Drug Administration said on Friday it approved new labeling for Sarepta Therapeutics' gene therapy Elevidys ...
Medpage Today on MSN
Gene Therapy Gets FDA's Strongest Warning After Fatal Liver Injuries
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 ...
Fierce Biotech
Patient dies after receiving Intellia's CRISPR therapy
The patient who was hospitalized after receiving Intellia Therapeutics’ CRISPR therapy nex-z has died. | The patient who was ...