Roche Holding AG (0QOK.IL)
- GlobeNewswire
Roche granted FDA Breakthrough Device Designation for blood test measuring Lp(a) – a key marker for hereditary cardiovascular risk
Approximately one in five people worldwide have elevated Lp(a) levels, putting them at increased risk of cardiovascular diseases including myocardial infarction and stroke.1The Roche Diagnostics Tina-quant® Lp(a) assay measures lipoprotein (a) in a person’s bloodstream, and will be made available on Roche’s installed base of over 90,000 serum work area (SWA) systems worldwide. The test has been developed in collaboration with Amgen. Basel, 22 May 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announc
- Zacks
Roche (RHHBY) Cancer Drug Gets Breakthrough Therapy Designation
Roche's (RHHBY) inavolisib gets Breakthrough Therapy Designation in the United States for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation.
- Business Wire
FDA Grants Breakthrough Therapy Designation to Genentech’s Inavolisib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer with a PIK3CA Mutation
SOUTH SAN FRANCISCO, Calif., May 21, 2024--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for inavolisib, an investigational oral therapy, in combination with palbociclib (Ibrance®) and fulvestrant, for the treatment of adult patients with PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic bre
