PU¶PubMed·Journal article·Regulatory & legal·4w agoLunsotogene Parvec: First ApprovalThis is the first approved dual-AAV gene therapy for congenital profound hearing loss; audiologists and CI teams should familiarise themselves with eligibility criteria and referral pathways as it enters clinical use.
Hearing Review·Regulatory·Regulatory & legal·3mo ago· press releaseEMA Accepts Otarmeni Gene Therapy for OTOF-Related Hearing Loss for ReviewEMA acceptance of the first gene therapy marketing application for hereditary hearing loss marks a pivotal regulatory moment that could fundamentally expand treatment options beyond conventional amplification and cochlear implants for a defined genetic subpopulation.＋Save
