New Drug Application (NDA)
FDA indicates it cannot approve Allergan’s new drug application for ulipristal acetate
Allergan has disclosed that it has received a complete response letter (CRL) from the US Food and Drug Administration indicating that it cannot approve the new drug application (NDA) submitted for ulipristal acetate. more
FDA accepts new drug application for iclaprim
Clinical-stage biopharmaceutical company, Motif Bio, has received acceptance from the US Food and Drug Administration (FDA) for the filing of its new drug application (NDA) for iclaprim to treat acute bacterial skin and skin structure infections more
Women are underrepresented in many clinical trials for heart drugs, according to research
Women are not represented well enough in clinical trials for many new heart drugs that are used in the support of new drug application (NDA) approvals, according to the authors of a recently published study in the JACC more
New treatment option for glaucoma approved by FDA
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
Complete response letter from FDA received by Ocular Therapeutix
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
Eyes on Santen: FDA accepts NDA for intravitreal sirolimus
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
ProvayBlue given FDA new drug application status
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
FDA grants venetoclax NDA status for leukaemia treatment
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
Novo Nordisk submits new drug application for faster-acting insulin aspart
Novo Nordisk has submitted a New Drug Application (NDA) for a faster-acting insulin aspart to the US Food and Drug Administration (FDA) more
FDA has accepted the first digital medicine product
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
FDA accepts Sanofi's NDA for basal insulin Toujeo
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
