Tag Archives: approval

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 »

Approval of at-home tests releases a pandemic-fighting weapon

The Food and Drug Administration (FDA) approved inexpensive, at-home coronavirus tests for over-the-counter sales this week, adding a potentially powerful weapon to the nation’s pandemic-fighting arsenal that experts say will likely still be needed despite increasing numbers of vaccinated Americans. One of them is Michael Mina, assistant professor of epidemiology, who has called on federal… 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 »

Novo’s Ozempic scores major win with heart-helping FDA approval. Is Rybelsus next?

After racing out to a fast start in its first year on the market, Novo Nordisk’s GLP-1 diabetes superstar Ozempic is already proving a darling for the Danish drugmaker. Now, a heart-helping FDA approval will likely spell even more success for the standout––and bodes well for Novo’s other much-touted diabetes launch. The FDA approved Ozempic to reduce the… Read More »

Global Blood’s sickle cell drug wins FDA approval, joining Novartis’ Adakveo

Dive Brief: The Food and Drug Administration on Monday approved Global Blood Therapeutics’ sickle cell drug voxelotor, completing a rapid review that took the regulator about 90 days. The accelerated OK is conditional on the biotech completing a study to confirm the rise in hemoglobin measured in trials so far yields clinical benefit. Global Blood… Read More »

Approval of golden rice could finally end vitamin A deficiency deaths

Genetically modified golden rice finally seems set for approval where it is needed to address vitamin A deficiency, but anti-scientific misinformation campaigns continue, says Michael Le Page Health | Comment 20 November 2019 By Michael Le Page Josie Ford AFTER a regulatory approval process lasting two years, Bangladesh is expected to soon green-light the cultivation… Read More »

Eversense Implantable Glucometer Gets FDA Approval as Alternative to Finger Tests

Senseonics, a company out of Germantown, Maryland, won FDA approval for its Eversense continuous glucose monitoring system. The system is intended to be used instead of traditional finger prick tests to make diabetes-related decisions. This is a giant step for the company, which has developed a technology that combines a tiny implant with a wearable… Read More »