Press Releases

Merck announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of ZEPATIER™ (elbasvir and grazoprevir), an investigational, once-daily, fixed-dose combination tablet for the treatment...

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...

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...

GSK, Fondazione Telethon and Ospedale San Raffaeletoday announced the publication in BLOOD of the long-term safety and efficacy data from an analysis of 18 children with ADA-SCID treated. with hematopoietic stem cell gene therapy between 2000...

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...