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FDA approves added indication for Genentech’s Lucentis

FDA approves added indication for Genentech’s Lucentis

08-02-2015

The US Food and Drug Administration on Friday approved Swiss pharma giant Roche subsidiary Genentech’s…

BiotechnologyGenentechLucentisNovartisOphthalmicsRegulationRocheUSA

Nicox holds successful pre-NDA meeting with FDA for AC-170

Nicox holds successful pre-NDA meeting with FDA for AC-170

26-01-2015

French ophthalmics company Nicox has held a positive pre-New Drug Application meeting with the US Food…

AC-170NicOxOphthalmicsPharmaceuticalRegulationUSA

Akorn files ANDA for generic Durezol

16-01-2015

US generic drugmaker Akorn has confirmed that it has filed an Abbreviated New Drug Application (ANDA)…

AkornAlconDurezolGenericsNovartisOphthalmicsPatentsRegulationUSA

Novartis' Alcon granted additional pediatric indication by the European Commission for Travatan

Novartis' Alcon granted additional pediatric indication by the European Commission for Travatan

23-12-2014

Eyecare specialist Alcon, the second-largest division of Swiss drug major Novartis, has been granted…

AlconNovartisOphthalmicsPharmaceuticalRegulationTravatanUSA

Regeneron gains further FDA indications for Eylea

Regeneron gains further FDA indications for Eylea

07-10-2014

The US Food and Drug Administration has approved biotech firm Regeneron Pharmaceuticals’ Eylea (aflibercept)…

BayerBiotechnologyEyleaOphthalmicsRegeneron PharmaceuticalsRegulationUSA

US FDA approves Iluvien for diabetic macular edema

US FDA approves Iluvien for diabetic macular edema

28-09-2014

US ophthalmic drug specialist Alimera Sciences says that the US Food and Drug Administration has approved…

Alimera SciencesIluvienMedidurOphthalmicsPharmaceuticalpSividaRegulationTethadurUSA

FDA grants Breakthrough status for Eylea in diabetic retinopathy in patients with DME

FDA grants Breakthrough status for Eylea in diabetic retinopathy in patients with DME

16-09-2014

US biotech firm Regeneron Pharmaceuticals says that the US Food and Drug Administration has granted Eylea…

BayerBiotechnologyEyleaOphthalmicsRegeneron PharmaceuticalsRegulationUSA

Genentech files sBLA for Lucentis for diabetic retinopathy

09-08-2014

Genentech, the biotech subsidiary of Swiss pharma major Roche, has submitted a supplemental Biologics…

BiotechnologyGenentechLucentisOphthalmicsRegulationRocheUSA

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