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 »

Teva Announces FDA Approval of Ajovy (fremanezumab-vfrm) Injection Autoinjector

Print this page PARSIPPANY, N.J.–(BUSINESS WIRE) January 28, 2020 — Teva Pharmaceuticals USA, Inc. an affiliate ofTeva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the Food and Drug Administration (FDA) has approved an autoinjector device for Ajovy® (fremanezumab-vfrm) injection. “The approval of the Ajovy autoinjector is another important step forward for Teva… Read More »

Seattle Genetics, Astellas snag quick FDA approval for bladder cancer-fighter Padcev

Historically, metastatic bladder cancer has been “a very bad prognosis,” in the words of Seattle Genetics CEO Clay Siegall. But his company and partner Astellas now have a shot at trying to change that. Wednesday, the FDA handed the duo an early approval for Padcev, a first-of-its kind antibody drug conjugate. The product targets Nectin-4, a protein… Read More »

Interview with Medtronic’s Mark Pacyna on Approval of IN.PACT AV DCB for Failing AV Fistulae

End-stage renal disease (ESRD) patients experiencing kidney failure typically require hemodialysis in order to artificially remove fluid and waste from blood and maintain appropriate electrolyte concentrations. For many patients on hemodialysis, an arteriovenous (AV) fistula is created to link an artery to a vein. Veins are too fragile for frequent access, but arteries are too… 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 »

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 »