Biocon Biologics secures market entry date for ophthalmology drug Yesafili in US Ruchika Sharma15 April 2025 4:18 PM ISTAdditionally, Biocon Biologics secured a settlement agreement in Canada with Bayer and Regeneron Pharma for launch of YESAFILI no later than July 1,...
Bayer files for approval of extended 6 month treatment interval for Eylea 8 mg in EU Ruchika Sharma11 Feb 2025 11:30 AM ISTBerlin: Bayer has submitted an application to the European Medicines Agency (EMA) to expand treatment intervals of up to 6 months with Eylea...
Biocon Biologics forays into US Ophthalmology market with USFDA nod for Yesafili Ruchika Sharma21 May 2024 11:30 AM ISTBengaluru: Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd, today announced that the U.S....
Bayer Eylea 8 mg gets Japanese marketing nod Ruchika Sharma21 Jan 2024 1:00 PM ISTBerlin: Bayer has announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted market authorization for Eylea 8 mg...
Regeneron asks US court to block Amgen Eylea biosimilar Ruchika Sharma12 Jan 2024 2:30 PM ISTThousand Oaks, California-based Amgen's proposed biosimilar would infringe 32 patents covering the manufacture and use of Eylea, Regeneron's lawsuit...
Bayer Eylea 8 mg approved in EU for treatment of two major retinal diseases Ruchika Sharma11 Jan 2024 3:30 PM ISTBerlin: Bayer has announced that the European Commission has granted marketing authorization in the European Union (EU) for new Eylea 8 mg...
Biocon arm gets UK MHRA marketing authorisation for ophthalmic drug Yesafili Ruchika Sharma14 Nov 2023 11:29 AM ISTIt is highly similar to the reference product Eylea (aflibercept).
US FDA declines to approve Regeneron's higher dose Eylea Ruchika Sharma30 Jun 2023 11:00 AM ISTRegeneron was seeking approval for the drug to treat wet AMD, the leading cause of blindness among the elderly, and two eye diseases that are common...
Regeneron Pharma gets USFDA nod for EYLEA Injection to treat preterm infants with retinopathy of prematurity Ruchika Sharma12 Feb 2023 3:00 PM ISTEYLEA is a VEGF inhibitor formulated as an injection for the eye.
Bayer submits Aflibercept 8 mg for regulatory approval in two major retinal eye diseases in EU Ruchika Sharma7 Feb 2023 2:15 PM ISTAflibercept 8 mg is being jointly developed by Bayer and Regeneron.
Regeneron gets six months of US pediatric exclusivity for Eylea injection Ruchika Sharma23 Oct 2022 3:30 PM ISTEYLEA is a VEGF inhibitor formulated as an injection for the eye
Lupin Gets CDSCO Panel nod To study LUBT017 Biosimilar to Eylea Dr. Divya Colin15 Oct 2022 6:00 PM ISTNew Delhi: Directing to appoint an independent data safety monitoring committee, the Subject Expert Committee (SEC) functional under Central Drug...
