Last Updated on December 31, 2023 by The Health Master
Tarrytown: Regeneron Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (USFDA) has approved EYLEA (aflibercept) injection to treat preterm infants with retinopathy of prematurity (ROP).
Following this first pediatric approval, EYLEA is now indicated to treat five retinal conditions caused by ocular angiogenesis.
“Retinopathy of prematurity is a leading cause of childhood blindness worldwide.”
“Until now, the only USFDA-approved treatment in common use was laser photocoagulation, a complex and lengthy procedure that permanently ablates retina tissue and is stressful not only for infant patients but also the family navigating a delicate time after a preterm birth,” said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron, and a principal inventor of EYLEA.
“For the first time, physicians will now have an USFDA approved medication in EYLEA to treat this heartbreaking disease in these smallest of patients.” “We thank the investigators and the many families who participated in the clinical trials.”
EYLEA is being jointly developed by Regeneron and Bayer.
USFDA gives nod for generic Lenalidomide capsules
USFDA gives approval for Glycopyrrolate Injection USP
USFDA gives approval for Diclofenac Sodium Topical Solution USP
USFDA approves this anemia drug for patients on dialysis
USFDA gives nod for Technetium Mertiatide Injection
USFDA tentative nod for Dolutegravir, Emtricitabine and Tenofovir Alafenamide tablets
Pharma employee held by Mumbai police in spurious injection case
Health officials warn of norovirus spike in England
USFDA issues Form 483 with 2 observations to Laurus Labs for Visakhapatnam facility
Dissolution test: Importance in Pharma Industry
Cosmetics: Chemicals in Nail Polish, Shampoo may raise Type 2 Diabetes risk
Updated list of Medical Device Testing Laboratories (MDTLs)
Lux level in Industry (Pharma, Cosmetics, Homeopathy & Medical Devices)
Latest IPC Alert – Indian Pharmacopoeia Commission
Latest Notifications regarding Pharmaceuticals
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon: