Sales of Amgen Inc.'s blockbuster EPO products are facing a further downturn, this time thanks to the Centers for Medicare & Medicaid Services (CMS), and the company's stock on Tuesday lost 3.7 percent as a result. (BioWorld Today)
SILVER SPRING, Md. - Members of the FDA's Oncologic Drug Advisory Committee on Thursday agreed to some degree with recent label changes to Amgen Inc.'s blockbuster EPO products, but also suggested a few further steps, proposing more studies and stricter guidelines on prescribing the red blood cell boosters. (BioWorld Today)
SILVER SPRING, Md. - Members of the FDA's Oncologic Drug Advisory Committee on Thursday agreed to some degree with recent label changes to Amgen Inc.'s blockbuster EPO products, but also suggested a few further steps, proposing more studies and stricter guidelines on prescribing the red blood cell boosters. (BioWorld Today)
Aastrom Biosciences Inc. received FDA clearance to begin a pivotal trial of its regenerative stem cell product in osteonecrosis of the femoral head. (BioWorld Today)