Press Releases

AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion, recommending the approval of saxa/dapa (saxagliptin and dapagliflozin) tablets for the treatment of adults with type-2 diabetes....

Gilead Sciences Inc announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Epclusa®. ...

CSL announced that the US Food and Drug Administration (FDA) has approved AFSTYLA® , CSL Behring’s novel long-lasting recombinant factor VIII single-chain therapy for adults and children with haemophilia A. AFSTYLA is indicated in adults and...

Daiichi Sankyo Company, Limited announced that it has launched the antiplatelet agent Efient® Tablets 20mg  (JAN: Prasugrel Hydrochloride; approval to market: January 20, 2016; NHI drug price listing: May 25, 2016) in Japan. Efient® is an...

Eisai Co Ltd announced that it will launch its in-house-discovered antiepileptic drug (AED) Fycompa® Tablets 2 mg and 4 mg (perampanel hydrate) as an adjunctive therapy for partial-onset seizures (including secondarily generalized seizures).   or primary...

Outlines actions underway to accelerate launch of Entresto®, including further expansion of US primary care field force, and reinforce strong uptake of Cosentyx® Highlights leading pipeline of second generation immuno-oncology assets. Confirms Sandoz on track for...

Sanofi announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. FDA recommended the approval of the NDA for the investigational fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the...