FDA is investigating a possible increased risk of death with the drug Ukoniq (umbralisib) approved to treat relapsed or refractory marginal zone lymphoma.
By law, the Food and Drug Administration is required to determine whether a drug, device, biologic, or medical device is “safe and effective.” But the FDA determination does not control whether the Centers for Medicare & Medicaid Services will pay for it. To satisfy CMS, medical products and services must be “reasonable and necessary,” meaning...
