Keeping Track: Approvals For Tazverik And Tepezza, Priority Reviews For Belantamab Mafodotin And Lynparza
The latest drug development news and highlights from our US FDA Performance Tracker.
You may also be interested in...
US FDA reviewers recommended against accelerated approval of Epizyme’s tazemetostat for epithelioid sarcoma, finding the modest overall response rates were not substantial evidence of an improvement over available therapies; they were overruled by senior oncology review staff, who cited a unanimous ODAC endorsement and the regulatory flexibility encouraged for rare diseases.
Stay-at-home restrictions due to COVID-19 have started to impact the company's vaccines business, including the big growth driver Shingrix.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.