Keeping Track: Regeneron’s Bispecific Bid, More Regenerative Medicine BLAs, And Vadadustat Returns
Executive Summary
Highlights of recent submissions for approval from the Pink Sheet’s US FDA Performance Tracker
You may also be interested in...
Kyowa Kirin Tries On New Genes With Orchard Buy
The Japan-based drug maker is hoping to expand into cell and gene therapy as well as enlarge its presence in the North American market, while Orchard awaits an FDA verdict on Libmeldy.
FDA Nod For Roche’s Columvi Brings Third Anti-CD20 Bispecific To Market
The company is touting the drug’s fixed-duration treatment as an advantage for patients, while the new drug class has ignited discussion around their use in the community oncology setting.
Keeping Track: Genmab/AbbVie Epkinly, Krystal’s Vyjuvek Join US FDA’s 2023 Novel Approvals List
Oncology's surprisingly low numbers this year are among the latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.