Mainz Biomed N.V., a molecular genetics diagnostic company specializing in the early detection of cancer, announced that it has submitted its application to the U.S. Food and Drug Administration (FDA) requesting Breakthrough Device Designation for its non-invasive Next Generation colorectal cancer (CRC) product including the Company’s novel portfolio of mRNA biomarkers. Subject to the FDA’s review, a Breakthrough Device Designation could significantly accelerate approval.
Otsuka wins FDA breakthrough therapy designation for IgAN drug – Pharmaceutical Technology
Share this article The FDA has granted breakthrough therapy designation following positive Phase II data released in November. Credit: grandbrothers via Shutterstock. After a high-profile
February 16, 2024