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Roche: reintroduces Susvimo - FDA validates updates
(CercleFinance.com) - Roche announces the reintroduction of Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via an ocular implant for the treatment of people in the US with neovascular or 'wet' age-related macular degeneration (nAMD), following the completion of a voluntary recall.
The US FDA has approved a post-approval supplement to the Biologics License Application for Susvimo, reflecting updates to the ocular implant and refill needle components.
Roche will work to make Susvimo available in the US for retina specialists and their nAMD patients in the coming weeks.
Susvimo's return to the retina community reflects our unwavering commitment to providing innovative retinal treatments, and sets the stage for future advances, says Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development.
Copyright (c) 2024 CercleFinance.com. All rights reserved.
The US FDA has approved a post-approval supplement to the Biologics License Application for Susvimo, reflecting updates to the ocular implant and refill needle components.
Roche will work to make Susvimo available in the US for retina specialists and their nAMD patients in the coming weeks.
Susvimo's return to the retina community reflects our unwavering commitment to providing innovative retinal treatments, and sets the stage for future advances, says Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development.
Copyright (c) 2024 CercleFinance.com. All rights reserved.