accelerated review

2 articles
GlobeNewswire Inc.GlobeNewswire Inc.··Fda

FDA Approves Regeneron's Landmark Gene Therapy for Genetic Hearing Loss in Record 61 Days

FDA approves $REGN's Otarmeni, first dual AAV gene therapy for genetic hearing loss, in record 61 days under priority voucher program. 80% of patients showed improved hearing.
REGNFDA approvalrare disease
GlobeNewswire Inc.GlobeNewswire Inc.··Robbins Llp

Inovio Pharmaceuticals Faces Class Action Over Device Manufacturing Disclosures

Inovio Pharmaceuticals faces class action lawsuit for allegedly misleading investors about device manufacturing capabilities and regulatory delays, leading to 24% stock decline.
INOsecurities fraudclass action lawsuit