FDA maintains constructive stance as Island Pharmaceuticals progresses Galidesivir clinical development

By on    Pharma & Biotech  

FDA maintains constructive stance as Island Pharmaceuticals progresses Galidesivir clinical development

Island Pharmaceuticals Limited has confirmed that the United States Food and Drug Administration (FDA) continues to evaluate its most recent regulatory submission related to Galidesivir, the company’s clinical-stage antiviral candidate being advanced under the Animal Rule pathway. In correspondence dated 2 January 2026, the regulator informed the Australian biotech firm that additional time is required […]

Atossa pivots into rare disease with FDA nod for (Z)-Endoxifen in Duchenne muscular dystrophy

By on    Pharma & Biotech  

Atossa pivots into rare disease with FDA nod for (Z)-Endoxifen in Duchenne muscular dystrophy

Atossa Therapeutics has received Rare Pediatric Disease (RPD) designation from the U.S. Food and Drug Administration for (Z)-Endoxifen in Duchenne muscular dystrophy (DMD), a strategic shift that positions the estrogen receptor modulator for possible use in pediatric neuromuscular disorders. If approved, the program could qualify for a transferable Priority Review Voucher, but the timeline and […]