regulatory approval

News

Bayer joins Boehringer with FDA approval for a second-line, oral therapy for HER2-positive lung cancer, setting up a marketing battle in the US.

News

Bayer now has approval on both sides of the Atlantic for Lynkuet, with the EU backing it for symptoms caused by both menopause and breast cancer.

News

Patients in the US and EU with follicular lymphoma have new treatment options, thanks to new approvals for CD20xCD3 bispecifics Lunsumio and Epkinly.

News

Kura has claimed FDA approval for oral menin inhibitor Komzifti for acute myeloid leukaemia, setting up a battle with Syndax's rival Revuforj.

News

Johnson & Johnson has clinched an FDA approval for Caplyta in depression, satisfying a major driver for its $14.6bn takeover of ICT this year.

News

People living with thymidine kinase 2 deficiency (TK2d), a vanishingly rare and often fatal genetic disorder, finally have an approved therapy.