Tag Archives: approval

Apervita’s NCQA approval helps health plans speed VBC analysis

Value-based care platform provider Apervita says it is the first company to be certified by the National Committee for Quality Assurance for electronic clinical quality measures using a clinical quality language-based engine. The company’s newly certified CQL-based engine—based on HL7 logic standards that support both eCQMs and clinical decision support—can be adopted by healthcare organizations… Read More »

Exelixis Announces U.S. FDA Approval of Cabometyx (cabozantinib) Tablets for Previously Treated Hepatocellular Carcinoma

Print this page ALAMEDA, Calif.–(BUSINESS WIRE)–Jan. 14, 2019– Exelixis, Inc. (NASDAQ:EXEL) today announced that the U.S. Food and Drug Administration (FDA) approved Cabometyx (cabozantinib) tablets for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. HCC is the most common form of liver cancer and the fastest-rising cause of cancer-related death in… Read More »

Horizon Pharma plc Announces FDA Approval to Expand the Age Range for Ravicti (glycerol phenylbutyrate) Oral Liquid to Include Newborns

Print this page DUBLIN–(BUSINESS WIRE)–Dec. 27, 2018– Horizon Pharma plc (NASDAQ: HZNP) today announced the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) to expand the age range for Ravicti (glycerol phenylbutyrate) Oral Liquid to include infants younger than two months of age living with a urea cycle disorder… Read More »

Merck suits up for another Opdivo showdown with Keytruda liver cancer approval

Merck just advanced the Keytruda-Opdivo immuno-oncology rivalry into a brand-new arena. On Friday, the FDA handed Keytruda a new approval in patients with hepatocellular carcinoma—the most common form of liver cancer in adults—who have already been treated with Bayer’s Nexavar. That’s a group for which regulators cleared Opdivo, Keytruda’s chief nemesis in the PD-1/PD-L1 class,… Read More »

Amicus Therapeutics receives U.S. approval for Fabry disease drug

(Reuters) – U.S. health regulators on Friday approved Amicus Therapeutics’ Galafold, the first oral therapy to treat Fabry disease, a rare, sometimes fatal condition in which accumulation of fat damages several organs. Galafold, known chemically as migalastat, will be the first new Fabry treatment on the U.S. market in over 15 years, and will compete… Read More »