HLB liver cancer drug hits FDA setback again over manufacturing issues

HLB's hopes of bringing its liver cancer treatment to the US market have suffered another blow after the US Food and Drug Administration issued a Complete Response Letter delaying approval, citing manufacturing compliance issues rather than concerns over the drug's clinical data.

HLB said Friday that its US subsidiary, Elevar Therapeutics, received the CRL from the FDA regarding its new drug application for Rivoceranib, an anti-cancer therapy intended for use in the treatment of liver cancer.

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