Setback for Genentech

Article

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.

Related Videos
Josefina Botta, MD, MSc, at ASCRS 2024
Dr Nir Shoham Hazon, Director, Miramichi EyeNB Centre of Excellence, New Brunswick, Canada
J. Morgan Micheletti, MD, speaks at the 2024 ASCRS meeting
Dr William Wiley of Cleveland Eye Clinic, Northeast Ohio
Related Content
Hemoglobin molecule structure, rendered in pink and purple. Generative AI. Image credit: ©Electro Unicorn – stock.adobe.com

TEASE-3 study: Positive interim data are reported for Stargardt drug

April 25th 2024
Article

Gildeuretinol halts Stargardt disease progression, study results indicate

A researcher sits at a computer. Image credit: ©lightpoet – stock.adobe.com

Interactive vision simulator illustrates the vision loss caused by retinal diseases

April 23rd 2024
Article

The online tool shows vision loss simulations for diabetic macular oedema, diabetic retinopathy, age-related macular degeneration and other retinal diseases

Professor Ramin Tadayoni, MD, PhD. Image courtesy of EURETINA

Retina community mourns sudden loss of Ramin Tadayoni, MD, PhD

April 22nd 2024
Article

Prof Tadayoni was a much-admired leader, researcher, surgeon and EURETINA President

A cell in amniotic fluid. Image credit: ©Icruci – stock.adobe.com

Amniotic membrane could move the needle outside of the operating room

April 19th 2024
Article

The tissue serves as a testing ground for outpatient ocular therapies

Concept image for an exhibition hall crowded with people. Image credit: ©arhendrix – stock.adobe.com

Clinicians and researchers don’t shy away from hot topics in the field

April 18th 2024
Article

The 15th annual Congress on Controversies in Ophthalmology heads to Athens, Greece

An elderly woman undergoes an eye exam. Image credit: ©cherryandbees – stock.adobe.com

I-SCREEN programme will use AI and OCT imaging to identify and monitor AMD

April 17th 2024
Article

I-SCREEN will bring together 12 institutions across Europe, including Queen’s University Belfast

© 2024 MJH Life Sciences

All rights reserved.