Roche (RHHBY) announced the FDA approval of a label expansion into biliary tract cancer, or BTC, for the Pathway anti-HER2/neu Rabbit Monoclonal Primary Antibody test. This test is now the first ...
The revision of labeling for products approved or submitted for approval under an abbreviated new drug application (ANDA) depends on the labeling of the listed drug referenced in the ANDA.
To potentially include adolescents and antibody persistence up to two years Saint Herblain (France), November 26, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, ...