FilingReader Intelligence
Zhaoke Ophthalmology's melphalan receives US FDA orphan drug status
July 30, 2025 at 05:02 PM UTC•By FilingReader AI
Zhaoke Ophthalmology Limited announced its melphalan formulation received Orphan Drug Designation from the US FDA for pediatric retinoblastoma, a rare eye cancer.
Successful development and approval would grant the company seven years of US market exclusivity, preventing FDA approval of other melphalan-based products for this indication.
This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com
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