Genentech bags first approval of breakthrough-designated drug in US
This article was originally published in SRA
Executive Summary
Genentech has made history in the US as the first company to have a Food and Drug Administration-designated breakthrough therapy gain market approval. The product is Gazyva (obinutuzumab/GA101), which has won approval in combination with chlorambucil as a therapy for treatment-naïve chronic lymphocytic leukemia (CLL)1.
You may also be interested in...
Keeping Track: US FDA's Rejection Of First RMAT BLA Blemishes Otherwise Positive Week Of Non-Oncology News
The latest non-oncology drug development news and highlights from our US FDA Performance Tracker.
Keeping Track: First RMAT Approval On The Horizon; Big Weeks For Merck, Lilly And Celgene
The latest drug development news and highlights from our US FDA Performance Tracker.
Moderna's Valera Takes mRNA Approach To Combat Zika
With new funding in hand, Moderna and its infectious disease venture Valera are going full-speed ahead with a Zika vaccine, taking an mRNA approach, which they said could be a more rapid strategy to try to stop the disease.