Novartis: FDA approves second indication for Kymriah
(CercleFinance.com) - The US Food and Drug Administration has approved Novartis' Kymriah for intravenous infusion in a second indication, the treatment of relapsed or refractory large B-cell lymphoma, the Swiss drugmaker said on Tuesday.
Last year, Kymriah became the first chimeric antigen receptor T cell (CAR-T) therapy to receive regulatory approval for the treatment of B-cell precursor acute lymphoblastic leukaemia.
Separately, Novartis has received approval from US antitrust regulators for its proposed acquisition of gene therapy company AveXis.
The waiting period required for companies under the Hart-Scott-Rodino Antitrust Improvements Act has expired, the company said.
The tender offer is scheduled to expire on Monday 14 May.
Copyright (c) 2018 CercleFinance.com. All rights reserved.
Last year, Kymriah became the first chimeric antigen receptor T cell (CAR-T) therapy to receive regulatory approval for the treatment of B-cell precursor acute lymphoblastic leukaemia.
Separately, Novartis has received approval from US antitrust regulators for its proposed acquisition of gene therapy company AveXis.
The waiting period required for companies under the Hart-Scott-Rodino Antitrust Improvements Act has expired, the company said.
The tender offer is scheduled to expire on Monday 14 May.
Copyright (c) 2018 CercleFinance.com. All rights reserved.