SWX:ROPPharmaceuticals
Roche (SWX:ROP) Wins FDA Clearance And EU Backing For Two Key Products
Roche Holding (SWX:ROP) received FDA 510(k) clearance for its cobas BV/CV molecular diagnostic assay, expanding its sexual health testing portfolio in the United States.
The assay is designed to support more accurate diagnosis of bacterial vaginosis and vulvovaginal candidiasis, two common women's health conditions that are often misdiagnosed.
The EMA’s Committee for Medicinal Products for Human Use issued a positive opinion for Susvimo, a ranibizumab implant for neovascular age related...