Hearing Review·Industry news·Research (general)·2w agoFDA Grants Accelerated Approval to Otarmeni Gene Therapy for OTOF-Related Hearing LossAudiologists should be aware that Otarmeni is now FDA-approved for OTOF-related hearing loss and begin familiarizing themselves with candidate identification (genetic testing referral pathways) and post-treatment audiological monitoring protocols, though prescribing authority...
Hearing Tracker·Regulatory·Regulatory & legal·3w agoFDA Approves Regeneron's Otarmeni, First Gene Therapy for Genetic Hearing LossAudiologists and ENT teams treating patients with the relevant genetic form of hearing loss should become familiar with Otarmeni's approved indication and refer eligible patients to gene therapy specialists; this is a practice-changing regulatory milestone.+Save