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  • Hanmi¡¯s Rolontis receives US FDA marketing approval
  • by Kim, Jin-Gu | translator Alice Kang | Sep 13, 2022 05:52am
Will be released in the US within the year
Hanmi¡¯s partner Spectrum receives approval of marketing authorization notice from the FDA
Hanmi Pharmaceutical¡¯s neutropenia treatment ¡®Rolontis (US product name: Rolvedon)' received approval from the US FDA.

Hanmi Pharmaceutical and its partner Spectrum Pharmaceuticals announced on the 9th (local time) that it had received written notice of approval allowing for the marketing authorization of Rolontis from the FDA.

This is the first new drug developed by Hanmi Pharmaceutical to be granted marketing authorization by the FDA. In terms of achievements made by the domestic biopharmaceutical industry, Hanmi Pharmaceutical¡¯s approval this time marks the 6th new homegrown drug MA granted by the FDA and is the first among new anticancer drugs

Hanmi Pharmaceutical and Spectrum Pharmaceuticals explained t
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