• 3 April 2018

    Sanofi seeks EMA approval for asthma drug Dupixent

    The European Medicines Agency (EMA) has accepted Sanofi’s application to review its drug Dupixent (dupilumab) as an add-on maintenance treatment in patients aged 12 years and older with inadequately controlled...

  • 15 March 2018

    FDA approves Biologics License Application for Xeomin

    Merz North America has announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (sBLA) for Xeomin (incobotulinumtoxinA) as a treatment for chronic sialorrhea.

  • 13 March 2018

    Sarepta to request FDA accelerated approval for DMD drug

    Sarepta Therapeutics has announced its plans to submit a New Drug Application (NDA) for accelerated approval of its drug golodirsen (SRP-4053), a treatment for the neuromuscular disorder Duchenne Muscular Dystrophy...

  • 16 February 2018

    Prostate cancer drug given approval by the FDA

    The US Food and Drug Administration (FDA) has approved Johnson & Johnson’s (J&J) next-generation prostate cancer drug apalutamide, to be sold under the brand name Erleada.