FDA denies Lilly appeal

Article

The FDA has denied Eli Lilly's appeal of the agency's ruling requiring it to conduct an additional three-year study of ruboxistaurin mesylate (Arxxant) before it can be approved for treating diabetic retinopathy (DR).

Recent Videos
Elizabeth Cohen, MD, discusses the Zoster Eye Disease study at the 2024 AAO meeting
Victoria L Tseng, MD, PhD, professor of ophthalmology and glaucoma specialist, UCLA
Brent Kramer, MD, of Vance Thompson Vision speaks at the 2024 AAO meeting
Related Content
A digital map of the world, overlaid on top of a photo of a person writing with a pen in a notebook. Image credit: ©Pixels Hunter – stock.adobe.com

Arctic Vision partners with Santen Pharmaceutical Co., Ltd. to commercialise ARVN001 in China

Sydney M Crago
November 22nd 2024
Article

ARVN001 is indicated for the treatment of uveitic macular oedema and certain other ophthalmic indications

Higher molar dose and its translation into clinical practice. Led by John Kitchens, MD; Joined by Peter Kaiser, MD

Higher Molar Dose and Its Translation into Clinical Practice

John Kitchens, MD;Peter Kaiser, MD
July 22nd 2024
Podcast
A syringe against a multicolor background, with a drip of liquid at the end of the needle. Image credit: ©iloli – stock.adobe.com

European Commission approves aflibercept biosimilar OPUVIZ (previously SB15) from Samsung Bioepis

Sydney M Crago
November 20th 2024
Article

OPUVIZ, previously known as the biosimilar candidate SB15, has been approved for the treatment of nAMD, DME and other retinal diseases

A European Union delegate signs a document while an EU flag is visible on the desk. Image credit: ©pressmaster – stock.adobe.com

CHMP issues positive opinion for marketing authorisation of aflibercept biosimilar FYB203 (Formycon)

Sydney M Crago
November 19th 2024
Article

The positive opinion marks a key regulatory step towards the approval of FYB203, which will go by the trade names AHZANTIVE and Baiama in the European Union

The FDA logo on a laptop computer. Image credit: ©monticellllo – stock.adobe.com

US FDA issues Complete Response Letter for avacincaptad pegol (Izervay, Astellas Pharma Inc)

Hattie Hayes;Jordana Joy
November 19th 2024
Article

The CRL comes in response to a supplemental New Drug Application for Izervay, a treatment for geographic atrophy secondary to age-related macular degeneration

A phone and a computer with the NHS website pulled up. The webpage on the phone says "NHS Services." Image credit: ©Timon – stock.adobe.com

NHS introduces OCT programme to reduce annual hospital visits for patients with diabetes

Hattie Hayes
November 18th 2024
Article

Optical coherence tomography will be in all eye care services by October 2025

© 2024 MJH Life Sciences

All rights reserved.