Tag Archives: Approval

Lilly’s Taltz (ixekizumab) Receives U.S. FDA Approval for the Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis

Print this page INDIANAPOLIS, March 30, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced today the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Taltz (ixekizumab) injection, 80 mg/mL for the treatment of pediatric patients (ages 6 to under 18) with moderate to severe plaque psoriasis… 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 »

Promising new sickle cell disease medicine wins FDA approval

This undated image provided by Novartis shows bottles of Novartis’s Adakveo. U.S. regulators have approved the new sickle cell disease medicine that can prevent extremely painful, dangerous “crises” in which misshapen blood cells clump together, reducing blood and oxygen flow. (Novartis via AP) After a recent decision by the FDA a better day could be… Read More »

FDA Grants Genentech’s Polivy (polatuzumab vedotin-piiq) Accelerated Approval for Adults With Previously Treated Aggressive Lymphoma

Print this page South San Francisco, CA — June 10, 2019 — Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Polivy (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan (rituximab) (BR) for the treatment of adults with relapsed or refractory (R/R)… 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 »

Viewpoints: Approval Of New Opioid Is A Huge Mistake; Passage Of SUPPORT Act Is Just The Beginning Of Solving The Opioid Crisis

Editorial writers weigh in on these health topics and others. The Washington Post: The FDA Made The Wrong Call On This Powerful, New Opioid Rejecting Dsuvia should have been a no-brainer. An FDA-approved intravenous version of sufentanil has been used by clinicians only in hospital settings for general anesthesia and for epidurals during labor and… Read More »