Persisting first through an FDA complete response letter (CRL), and then through a denial of a formal dispute resolution request, Akebia Pharmaceuticals is now counting on Japanese postmarketing safety data to get vadadustat, its chronic kidney disease (CKD) anemia drug, over the finish line in the U.S. Read More

Medicare will pay for treatment with any antiamyloid antibody that is fully approved by the FDA and administered as part of a national registry run by CMS, according to the agency. Read More

The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended pulling a Novartis sickle cell disease drug from the market and approving two others to diagnose prostate cancer and treat a certain form of epilepsy. Read More