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 »

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 »

AstraZeneca, Daiichi’s breast cancer drug gets accelerated approval from FDA

FILE PHOTO: The company logo for pharmaceutical company AstraZeneca is displayed on a screen on the floor at the New York Stock Exchange, U.S., April 8, 2019. REUTERS/Brendan McDermid (This Dec.20 story corrects first paragraph to say the approval came four months ahead of schedule, not three months, after FDA clarification) (Reuters) – The U.S.… 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 »

KemPharm Announces FDA Approval of sNDA for Two Additional Strengths of Apadaz (4.08 mg benzhydrocodone/325 mg APAP and 8.16 mg benzhydrocodone/325 mg APAP)

Print this page CORALVILLE, Iowa, Jan. 07, 2019 (GLOBE NEWSWIRE) — KemPharm, Inc. (NASDAQ:KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, announced today that the U.S. Food and Drug Administration (FDA) has approved a Supplemental New Drug Application (sNDA) for two additional strengths of Apadaz, an immediate release (IR)… Read More »