Safety – Page 2

Sarepta Reports Third Patient Death in Gene Therapy Studies for Limb-Girdle Muscular Dystrophy

1 month ago talkbio0Tagged AAVS1 gene, ELEVIDYS, gene therapy, Liver Failure, Acute, Muscular Dystrophies, Limb-Girdle, Patient Death, Safety, Study on Hold, United States Food and Drug Administration, vector

Sarepta Therapeutics; limb-girdle muscular dystrophy; SRP-9004; gene therapy; patient death; acute liver failure; FDA clinical hold; AAV vector; Elevidys; safety concerns

FDA Advisory Panel Rejects GSK’s Blenrep in New Combinations Over Safety, Efficacy Concerns

1 month ago talkbio0Tagged Advisory Panel, Blenrep, concerns, DREAMM, Drug Approval, Multiple Myeloma, Ocular Toxicity, Refractory Plasma Cell Myeloma, Relapsing course, Safety, SmithKline Beecham, trials, United States Food and Drug Administration

Blenrep; GSK; FDA Advisory Panel; multiple myeloma; ocular toxicity; safety concerns; DREAMM trials; drug approval; relapsed or refractory multiple myeloma

EU Lifts Restriction on Valneva’s Chikungunya Vaccine for Older Adults, Recommends Caution

1 month ago talkbio0Tagged Adverse event, chikungunya vaccine, concerns, Elderly (population group), European Medicines Agency, Ixchiq, label extension, Safety, Valneva

Valneva; Chikungunya vaccine; IXCHIQ; European Medicines Agency; older adults; safety concerns; label extension; adverse events

FDA Approves Updated Dosing for Lilly’s Kisunla to Lower Brain Swelling Risk

1 month ago talkbio0Tagged Alzheimer 's disease, Cerebral Edema, dosing, eli lilly, Kisunla, label update, Neuregulins, Safety, Treatment Protocols, United States Food and Drug Administration

FDA; Kisunla; Eli Lilly; Alzheimer’s disease; dosing regimen; brain swelling; ARIA; safety; label update; TRAILBLAZER-ALZ 6

Zealand Pharma’s Dual GLP-1/GLP-2 Agonist Dapiglutide Shows Promising 11.6% Weight Loss at 28 Weeks

2 months ago talkbio0Tagged Clinical Trials, Dapiglutide, Glucagon-Like Peptide 1, Glucagon-Like Peptide 2, Obesity, Safety, Weight Loss, Zealand Pharma

Zealand Pharma; dapiglutide; GLP-1; GLP-2; weight loss; obesity; phase 1b trial; clinical trial; dual agonist; safety

Merck Advances Middle Dose of ROR1 ADC in Relapsed/Refractory DLBCL After Safety Review

3 months ago talkbio0Tagged Adverse event, Clinical Trials, Diffuse Large B-Cell Lymphoma, Merck, middle dose, Relapsing course, ROR1 protein, human, Safety, therapeutic autologous dendritic cells, Unresponsive to Treatment, vedotin, waveLINE-003, Zilovertamab

Merck; ROR1; ADC; zilovertamab vedotin; middle dose; 1.75 mg/kg; relapsed DLBCL; refractory DLBCL; WaveLINE-003; safety; adverse events; clinical trial; ASCO 2025

Analysts Downplay Intellia Adverse Event, but Gene Therapy Safety Remains Under Scrutiny

3 months ago talkbio0Tagged Adverse event, ATTR-CM, Event, Gene Modification, gene therapy, Intellia, liver transaminase, MAGNITUDE trial, Response process, Safety, Stock Decline

Intellia Therapeutics; gene therapy; safety event; adverse event; MAGNITUDE trial; liver transaminase; stock decline; ATTR-CM; gene editing; analyst response