The European Union’s drug regulator on November 19 advised that an experimental Covid-19 pill from Merck should be given within five days of first symptoms to treat adults who do not need oxygen support and are at risk of their disease worsening.
Bayer won an endorsement from the European Union’s drug regulator for the company’s prostate cancer drug darolutamide, putting the medicine on track for approval to take on rival products from Pfizer and Johnson & Johnson.
European drug panel recommends approving Novo Nordisk’s new diabetes pillBlockbusters, Committee for Medicinal Products for Human Use (CHMP), Diabetes, European Commission, European Medicines Agency (EMA), FDA/Regulatory, First-of-its kind, Glucagon-Like Peptide-1 (GLP-1) Analogs, Injectables, Recommended For Approval, Type 2 Diabetes
A panel of the European medicines regulator recommended approving Novo Nordisk’s new diabetes pill Rybelsus, further boosting prospects for the Danish drugmaker with the company’s first-of-a-kind, non-injectable treatment.
Johnson & Johnson’s Spravato, a nasal spray for depression and potential blockbuster medicine, won recommendation for approval from a European Medicines Agency panel.
The world’s first Ebola vaccine was recommended for approval by European drug regulators in a move hailed by the World Health Organization (WHO) as a “triumph for public health.”
The EMA recommended approving Vitrakvi to tackle tumors with a specific genetic mutation regardless of where the disease started.
GW Pharmaceuticals’ marijuana-based treatment Epidyolex won a positive recommendation for marketing approval from a European Medicines Agency (EMA) panel for use as an additional treatment for two types of seizures.
The U.S. Food and Drug Administration approved Pfizer Inc.’s biosimilar to Roche Holding AG’s blockbuster cancer treatment Avastin.
GlaxoSmithKline’s two-drug treatment for HIV infections won marketing approval from a European Medicines Agency panel. The British drugmaker received U.S. FDA approval in April 2019.
EU panel approves drug for rare genetic diseaseBlood, Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency (EMA), Familial Chylomicronemia Syndrome (FCS), Fat Accumulation, FDA, FDA/Regulatory, Inflammation, Pancreas, Platelet Count, Rare Genetic Diseases, Recommended For Approval
An advisory committee of the EMA recommended conditionally approving a drug from Akcea Therapeutics and Ionis Pharmaceuticals that aims to treat a rare genetic disease.