Novartis: FDA denies approval for Sandoz biosimilar
(CercleFinance.com) - Novartis has said that US health regulators have not approved its proposed biosimilar of Roche's lymphoma and leukaemia drug rituximab.
The drugmaker has said that the US Food and Drug Administration (FDA) has issued a complete response letter asking for additional information relating to its biologics license application (BLA) seeking approval of the antibody, developed by its division Sandoz.
Novartis shares are up 0.2% in late morning trading on the SIX Swiss Exchange this Thursday.
Copyright (c) 2018 CercleFinance.com. All rights reserved.
The drugmaker has said that the US Food and Drug Administration (FDA) has issued a complete response letter asking for additional information relating to its biologics license application (BLA) seeking approval of the antibody, developed by its division Sandoz.
Novartis shares are up 0.2% in late morning trading on the SIX Swiss Exchange this Thursday.
Copyright (c) 2018 CercleFinance.com. All rights reserved.