The U.S. Food and Drug Administration approved Novo Nordisk’s Rybelsus (semaglutide) tablets 7 mg or 14 mg for adults with type 2 diabetes that along with diet and exercise may improve blood sugar.
The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.
The top performers of the launch class of 2016 have very little in common – aside from the fact that none of them came from a “classic” big pharma house.
U.S. health officials said there are 530 confirmed and probable cases and seven deaths from severe lung-related illnesses tied to vaping, and there are no signs that the outbreak is easing.
An independent expert panel to the U.S. FDA recommended approval of GlaxoSmithKline Plc’s over-the-counter nicotine oral spray that aims to help smokers quit their addiction.
The U.S. Food and Drug Administration gave the green light to Johnson & Johnson’s Janssen for Erleada (apalutamide) as a treatment for metastatic castration-sensitive prostate cancer.
Verrica Pharmaceuticals Inc. submitted a New Drug Application to the U.S. Food and Drug Administration for VP-102 (cantharidin 0.7% topical solution) for the treatment of molluscum contagiosum.
The FDA greenlit GlaxoSmithKline’s Nucala (mepolizumab) for treating severe eosinophilic asthma in children as young as 6 years.
Zelnorm was relaunched by Alfasigma USA for the treatment of irritable bowel syndrome with constipation (IBS-C).
The U.S. Food and Drug Administration approved South African drugmaker Aspen Pharmacare’s hydroxyprogesterone caproate (HPC), which is used to prevent preterm birth in pregnant women.
Checkpoint Surgical Inc. – a leader in hand-held, intraoperative neurostimulation technology for nerve protection and repair – received Breakthrough Device designation from the U.S. Food and Drug Administration for the Checkpoint brief electrostimulation therapy (BEST) system.
The Trump administration announced plans to remove all flavored e-cigarettes from store shelves in a widening crackdown on vaping, as officials warned that sweet flavors had drawn millions of children into nicotine addiction.