Tag Archives: Approval

Regeneron Asks F.D.A. for Emergency Approval for Drug That Trump Claimed Cured Him

The drug maker Regeneron said on Wednesday evening that it had submitted an application to the Food and Drug Administration for emergency approval of the experimental antibody cocktail that President Trump had praised just hours earlier without evidence as a “cure” for the coronavirus. The company said that at first, access to the treatment would… Read More »

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 »

Genentech Announces FDA Approval of Xofluza (baloxavir marboxil) for People at High Risk of Developing Influenza-Related Complications

Print this page South San Francisco, CA — October 17, 2019 — Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza™ (baloxavir marboxil) for the treatment of acute, uncomplicated influenza, or flu, in people 12 years of… Read More »

Feds continue to refuse to make CBD legal without explicit FDA approval

(Photo: Adobe Stock) This week, the Food and Drug Administration (FDA) reiterated that hemp-derived cannabidiol, also known as CBD oil, is illegal to add to food, beauty or health products without prior FDA approval, or to make health claims for CBD. Despite the big farm bill President Trump signed off on this week which designates… 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 »