The US Food and Drug Administration (FDA) has granted approval for Sandoz's Enzeevu (aflibercept-abzv) 2mg vial kit and pre-filled syringe for intravitreal injection, a biosimilar aimed at treating neovascular age-related macular degeneration (nAMD).
MSD (Merck & Co) has completed the acquisition of EyeBio, making it a wholly-owned subsidiary, and bolstering its ophthalmology portfolio.
Beacon Therapeutics has announced a successful $170m Series B funding round, led by Forbion, to accelerate the development of its ophthalmic gene therapies, including its lead asset AGTC-501.
The US Food and Drug Administration (FDA) has granted approval to Formosa Pharmaceuticals and AimMax Therapeutics’ clobetasol propionate ophthalmic suspension 0.05% for post-operative inflammation and pain after ocular surgical procedure.
Entos Pharmaceuticals has inaugurated a new Good Manufacturing Practices (GMP) manufacturing facility in Carlsbad, California in the US.
BlueRock Therapeutics has exercised its exclusive option to license induced pluripotent stem cell (iPSC)-derived cell therapy candidate from FUJIFILM Cellular Dynamics and Opsis Therapeutics.
Novartis has concluded the sale of its ‘front of eye’ ophthalmology assets to eye health company Bausch + Lomb for up to $2.5bn.
US eyecare pharmaceutical company Harrow has signed agreements with affiliates of Santen Pharmaceutical to acquire certain US and Canadian commercial rights for some of the branded ophthalmic products from the latter.
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Regeneron Pharmaceuticals for its Biologics License Application (BLA) for aflibercept 8mg to treat wet diabetic macular oedema (DME), age-related macular degeneration (wAMD) and diabetic retinopathy (DR).
The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to HuidaGene Therapeutics’ HG004 gene replacement therapy.
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