Cessation of life
FDA Suspends Valneva’s Chikungunya Vaccine, Ixchiq, Due to Serious Safety Concerns
FDA; Valneva; Ixchiq; chikungunya vaccine; license suspension; safety; serious adverse events; encephalitis; hospitalizations; deaths
Sarepta Stands Behind Elevidys After FDA Requests Withdrawal Amid Safety Concerns
Sarepta; Elevidys; FDA; gene therapy; market withdrawal; safety concerns; Duchenne muscular dystrophy; deaths; clinical trial hold
UK approval brings GSK’s Blenrep back from the brink
UK, Approved, Multiple Myeloma, DREAMM-8, dexamethasone, Blenrep, Antibody-Drug Conjugates, Risk, Cessation of life
Beam Therapeutics Reports Promising Early Results in Sickle Cell Disease Base Editing Therapy, Despite Conditioning-Related Fatality
Beam Therapeutics, Sickle Cell Disease, Base Editing, Gene Therapy, BEAM-101, ESCAPE, Conditioning, Patient Death
FDA Halts Kezar’s Lupus Nephritis Trial Due to Safety Concerns Following Four Patient Deaths
FDA, Kezar Life Sciences, lupus nephritis, zetomipzomib, clinical hold, patient deaths, safety concerns
Kezar Life Sciences Suspends Enrollment and Dosing in Phase 2b PALIZADE Trial Due to Safety Concerns
Kezar Life Sciences, PALIZADE trial, zetomipzomib, lupus nephritis, safety concerns, patient deaths, clinical trial halt
FDA Places Partial Clinical Hold on Zentalis’ Azenosertib Cancer Studies Following Two Sepsis Deaths
Zentalis Pharmaceuticals, azenosertib, FDA, partial clinical hold, cancer studies, sepsis deaths, WEE1 inhibitor, clinical trials, patient safety
Ozempic Reduces Mortality Risk by 20% in Diabetes Patients with Chronic Kidney Disease
** Ozempic, Novo Nordisk, diabetes, chronic kidney disease, mortality risk, cardiovascular deaths, kidney failure, semaglutide, Wegovy, obesity treatment
J&J Adjusts Dosing Strategy for Actinium Prostate Cancer Drug Following Early Study Setbacks
J&J, Johnson & Johnson, actinium prostate cancer drug, capped dosing, flexible dosing, patient deaths, early study, clinical trial, cancer treatment, drug development.
MacroGenics Reviews Safety Protocols Following Three Patient Deaths in Prostate Cancer Drug Trial
MacroGenics, Phase 2 trial, prostate cancer, patient deaths, safety review, margetuximab, bispecific antibody