Roche PTEN diagnostic gets FDA approval for prostate cancer
The Ventana PTEN assay helps identify patients with PTEN-deficient prostate cancer for targeted therapy with TRUQAP.
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Pharmaceuticals and diagnostics company
roche.comLast updated
In short: Roche achieved multiple FDA milestones for cancer therapies and advanced its obesity pipeline while warning of Swiss labor and price pressures.
The Ventana PTEN assay helps identify patients with PTEN-deficient prostate cancer for targeted therapy with TRUQAP.
The filing is supported by phase III ATOMIC data showing Tecentriq plus chemotherapy halves recurrence risk compared to chemotherapy alone.
The deal covers oncology, immunology, and neurology. Roche pays $700M upfront, potential $2.3B total.
The NDA is for ER-positive early-stage breast cancer, based on phase III lidERA data showing 30% risk reduction in invasive disease recurrence or death.
The US drug authority is reviewing a new Roche combination against aggressive lymphatic cancer. Study data show clear benefits for patients.
Roche has submitted a supplemental application to the US Food and Drug Administration (FDA) for the combination of Lunsumio Velo and Polivy for the treatment of adults with an aggressive form of...
FDA review is now underway for Lunsumio VELO plus Polivy in relapsed or refractory LBCL. Decision due by Feb. 9, 2027, after SUNMO data.
Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the...
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