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The corticosteroid dexamethasone has earned the blessing of the EMA’s Committee for Medicinal Products for Human Use (CHMP) for treating COVID-19 patients who require oxygen therapy. Read More
Manufacturers of dexamethasone can request the new indication be added to their product’s licenses by submitting applications to national medicines agencies or the EMA. Read More
Jardiance is currently approved to lower blood sugar in adults with type 2 diabetes and for reducing the risk of cardiovascular death in patients with type 2 diabetes and known cardiovascular disease. Read More
The FDA has hit Mallinckrodt Pharmaceuticals with a second complete response letter (CRL), denying approval of its new drug application (NDA) for terlipressin for the treatment of adults with hepatorenal syndrome type 1(HRS-1) and calling for more data. Read More
In another hurdle for BioMarin Pharmaceutical’s investigational hemophilia A gene therapy valoctocogene roxaparvovec, the European Medicines Agency (EMA) has now asked the company to provide a full one-year follow up data from its ongoing phase 3 trial. Read More
The FDA has approved GlaxoSmithKline’s (GSK) and Innoviva’s Trelegy Ellipta (fluticasone furoate /umeclidinium /vilanterol) as a maintenance treatment for asthma in patients ages 18 years and older whose asthma is uncontrolled with inhaled corticosteroids and long-acting beta agonist therapy. Read More