Setback for Genentech
The FDA has denied Genentech's request to fast-track the application for its age-related macular degeneration (AMD) agent, Lucentis (ranibizumab). In response, Genentech announced it plans to file a complete Biologics License Application (BLA) for Lucentis for the treatment of neovascular AMD in December 2005, in a bid to speed up the process. Although the FDA rejected Genentech's request for fast-track designation, this should not affect the timing for BLA submission or the potential to obtain priority review.
Newsletter
Join ophthalmologists across Europe—sign up for exclusive updates and innovations in surgical techniques and clinical care.
Recent Videos
