Press Releases
Positive CHMP opinion in EU for saxa/dapa (saxagliptin and dapagliflozin) for adults with type-2 diabetes
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....
Press Releases
European CHMP Adopts Positive Opinion for Gilead’s Epclusa for the Treatment of All Genotypes of Chronic Hepatitis C
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®. ...
Press Releases
Merck receives positive CHMP opinion for Zepatier in the EU
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 ZEPATIERâ„¢ (elbasvir and grazoprevir), an investigational, once-daily, fixed-dose combination tablet for the treatment...
Press Releases
The EC grants the European marketing authorization to StrimvelisTM
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...
Press Releases
U.S. FDA Approves CSL Behring’s AFSTYL for adults and children with haemophilia A
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...
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FDA Recommends Approval Of Sanofi Treatment For Adults With Type 2 Diabetes
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...
Press Releases
GSK, Fondazione Telethon and Ospedale San Raffaele announce publication of pivotal safety and efficacy of gene therapy for children with ADA-SCID
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...
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