Toxicity aspects
FDA Advisory Committee Votes Against GSK’s Blenrep in Multiple Myeloma
FDA Advisory Committee; Blenrep; GSK; multiple myeloma; ODAC vote; drug safety; ocular toxicity; clinical trials
FDA Flags Eye Safety Concerns as GSK Seeks Blenrep’s US Return
GSK; Blenrep; FDA; eye safety; ocular toxicity; advisory committee; multiple myeloma; drug approval; United States; relapsed/refractory multiple myeloma
FDA Investigates Patient Deaths Linked to Sarepta’s Elevidys Gene Therapy for Duchenne Muscular Dystrophy
FDA; Sarepta; Elevidys; Duchenne muscular dystrophy; gene therapy; patient deaths; acute liver failure; liver toxicity; regulatory investigation; non-ambulatory patients
FDA puts Vyne in a twist, slapping hold on psoriasis trial over testicular toxicity concerns
Vyne, United States Food and Drug Administration, Testiculo-, Toxicity aspects, Study on Hold, United States Food and Drug Administration
Elion nets $81M to fund development of antifungal with lower toxicity risks
Antifungal Agents, Lower – spatial qualifier, Toxicity aspects, Risk, Elion
Biomea’s Early-Stage Diabetes Drug Placed on Full Clinical Hold, Stock Plummets
Biomea, diabetes, clinical hold, FDA, BMF-219, liver toxicity, stock crash
Tango Pauses Clinical Trials of Promising Solid Tumor Treatment Due to Liver Toxicity Concerns
Tango Therapeutics, solid tumor treatment, clinical trials, liver toxicity, drug development, cancer research, treatment side effects, patient safety.
Brukinsa by BeiGene Secures FDA Approval for Follicular Lymphoma Amid Imbruvica Setbacks
Brukinsa (zanubrutinib), BeiGene, FDA approval, follicular lymphoma, accelerated approval, obinutuzumab (Gazyva) combination therapy, ROSEWOOD trial, overall response rate (ORR), disease progression or unacceptable toxicity, competition with CAR-T cell therapies/ bispecific antibodies