Tag Archives: approval

Pfizer to Seek Approval for Booster COVID Shot, But U.S. Agencies Balk at Timing

By Ernie Mundell and Robin Foster HealthDay Reporters FRIDAY, July 9, 2021 — Pfizer and its partner BioNTech announced Thursday they would seek approval for a booster COVID-19 shot and begin studies on a reformulated vaccine that targets the highly contagious Delta variant. “We continue to believe that it is likely, based on the totality… Read More »

Chiesi Global Rare Diseases Announces FDA Approval of Ferriprox (deferiprone) for Treatment of Transfusional Iron Overload due to Sickle Cell Disease

May 1, 2021 Approval is based on demonstrated reduction in liver iron concentration Expanded indications for patients with sickle cell disease or other anemias, as well as thalassemia – BOSTON, May 1, 2021 /PRNewswire/ — Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), announced today… 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 »

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 »