Press Releases

AbbVie , Eisai Co Ltd. and its subsidiary EA  Pharma Co Ltd. announced the additional approval for a new dosing regimen of Humira® Pre-filled Syringe 40 mg/0.8 mL for Subcutaneous Injection (generic name: adalimumab , “Humira”). ...

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...

GlaxoSmithKline (GSK), Fondazione Telethon (Telethon) and Ospedale San Raffaele (OSR) announced that the European Commission has approved Strimvelis, the first ex-vivo stem cell gene therapy to treat patients with a very rare disease called ADA-SCID (Severe Combined Immunodeficiency due...

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...