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New Drug Application (NDA)

A new drug application (NDA) for VYZULTA — a prostaglandin analogue indicated for the reduction of intraocular pressure (IOP) — has been approved by the US Food and Drug Administration (FDA). more

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Biopharmaceutical company focused on the development, manufacture and commercialisation of therapies for ocular conditions, Ocular Therapeutix, has received a complete response letter regarding its resubmission of a new drug application more

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Santen Pharmaceuticals has announced that the FDA has accepted the new drug application (NDA) for intravitreal (IVT) sirolimus for the treatment of non-infectious uveitis of the posterior segment (NIU-PS). more

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Pharma development company, Provepharm’s ProvayBlue (methylene blue) Injection has been given New Drug Application status from the US Food and Drug Administration (FDA) under its accelerated approval regulations more

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The US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and granted Priority Review for Genentech’s venetoclax for the treatment of chronic lymphocytic leukaemia (CLL) more

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Novo Nordisk has submitted a New Drug Application (NDA) for a faster-acting insulin aspart to the US Food and Drug Administration (FDA) more

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Aripiprazole has been combined with an ingestible sensor to create a combination product, Abilify, which has New Drug Application (NDA) acceptance from the Food and Drug Administration (FDA) more

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The acceptance of the NDA follows the acceptance of the marketing authorization dossier for Toujeo by the European Medicines Agency (EMA) for EU countries on 27 May 2014. more