Pharmaceuticals, Biotechnology and Life Sciences
Novo Nordisk has submitted a Biologics License Applications (BLA) to the US Food and Drug Administration (FDA) and a Marketing…
Sanofi has asked the European Medicines Agency (EMA) to review fexinidazole for the treatment of sleeping sickness. Fexinidazole is being…
Santhera Pharmaceuticals will still remain without extension application for Raxone in Duchenne muscular dystrophy (DMD) in Europe, as expected. The…
The FDA has set Novartis’s Kymriah suspension injection for patients who have relapsed or refractory diffuse large B-cell lymphona (DLBCL)…
Novartis division Sandoz has gotten acceptance for its biosimilar to Amgen’s Neulasta by the European Medicines Agency (EMA) for regulatory…
European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for CTI BioPharma’s pacritinib for the treatment of patients with myelofibrosis who have thrombocytopenia.
The number of new drugs approved for sale in United States and Europe has bounced back this year, suggesting a marked slowdown in 2016 was an aberration rather than a sign of flagging research and development productivity.
European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorization of Sanofi and Regeneron Pharmaceuticals joint developed product Kevzara (sarilumab), recommending its approval for use in adult patients with moderately to severely active rheumatoid arthritis.
Amryt is on track to begin the phase 3 trial at the end of March for its new skin healing treatment in an orphan disease, with regulatory authority discussions now completed with Food and Drug Administration (FDA) and European Medicines Agency (EMA) and the design of the clinical trial established.
TiGenix has received the Day 180 List of Outstanding Issues (LoOI) from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and expects to receive a Marketing Authorization decision for Crohn’s disease drug Cx601 in 2017.