Gilead Sciences Inc said the U.S. Food and Drug Administration had approved its HIV drug cocktail, Genvoya, to treat patients aged 12 and above. Genvoya, a combination tablet approved as […]
European drug regulators have found no safety concerns linking GlaxoSmithKline’s and Merck’s cervical cancer vaccines with two conditions known as complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome […]
Regeneron Announces EU Approval of EYLEA (aflibercept) Injection for the Treatment of Visual Impairment Secondary to Myopic Choroidal Neovascularization
Approvals, Approvals, Biopharma, Collaboration, Collaborations, EMA, Health, Myopic Choroidal Neovascularization (Myopic CNV, Ophthalmics, Ophthalmology, Therapeutics, Vascular Endothelial Growth Factor (VEGF) InhibitorsTARRYTOWN, N.Y., Oct. 30, 2015 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that Bayer HealthCare has received European approval for EYLEA® (aflibercept) Injection for the treatment of visual […]
Europe’s medicines regulator recommended the suspension of Medtronic Plc’s Inductos, an implant used to help bone development, pending the resolution of issues at a U.S. site where a component is […]
Amgen wins EU green light for first virus-based cancer drug
Approvals, Approvals, BRAF V600 Inhibitors, BRAF V600 inhibitors, Cancer Cells, EMA, FDA, FDA/Regulatory, Health, Herpes, Herpes Simplex Virus, Immune Response, Immunotherapies, Immunotherapy, M&A, M&A, MEK Inhibitors, MEK Inhibitors, Melanoma, New Drug ApprovalsA first-in-class drug from Amgen based on a tumor-killing virus was given a green light by European regulators on Friday, paving the way for its approval within a couple of […]
PTC Therapeutics Inc’s experimental muscle disorder drug failed to meet the main goal in a keenly watched late-stage study, but the company said data from all trials on the drug […]
A biotech company founded by a Nobel prize winner has won the go-ahead from European regulators to begin the application process for conditional marketing authorization of a stem cell-based regenerative […]
