Tuesday, December 10, 2019

Tuesday, December 10, 2019

Latest News

SURMODICS: The Surmodics Sundance™ Sirolimus-Coated Balloon Catheter Earns FDA Breakthrough Device Status

Sundance™ Sirolimus-Coated Balloon will receive prioritization throughout the FDA submission and review process to provide patients and physicians timely access to medical devices

U.S. FDA: Statement on new testing results, including low levels of impurities in ranitidine drugs

Americans deserve to have confidence in the quality of drugs the U.S. Food and Drug Administration regulates – from the prescription medicines they take to the over-the-counter (OTC) products they use in their daily lives.

U.S. FDA: Authorizes marketing of first next-generation sequencing test for detecting HIV-1 drug resistance mutations

Today, the U.S. Food and Drug Administration authorized marketing of a test to detect human immunodeficiency virus (HIV) Type-1 drug resistance mutations using next generation sequencing (NGS) technology.

WELLDOC, INC: Welldoc's Award-winning Digital Health Solution BlueStar Adds FDA-Clearance for Use in Type 1 Diabetes

This is the 7th FDA 510(k) clearance for BlueStar, which was initially cleared for adults with type 2 diabetes

3D SYSTEMS: Expands its Industry-Leading Portfolio of Dental Materials with Newly FDA-Cleared NextDent® Denture 3D+

Dental labs and clinics can produce dentures 75% faster with 90% lower cost using 3D Systems' Digital Denture Workflow

EIP PHARMA: Announces U.S. FDA Grants Fast-Track Designation to Neflamapimod as a Treatment for Dementia with Lewy Bodies (DLB)

Phase 2 clinical trial of neflamapimod in patients with mild-to-moderate DLB currently enrolling patients in the U.S. and the Netherlands

TRANSTHERA BIOSCIENCES: Lead Product TT-00420 Granted Orphan Drug Designation from FDA to Treat Cholangiocarcinoma

TransThera Biosciences Co. Ltd, announced today that company received Orphan Drug Designation from US Food and Drug Administration (FDA) for TT-00420, a clinical stage investigational drug, for the treatment of cholangiocarcinoma.

U.S. FDA: Approves first therapy to treat patients with rare blood disorder

Today the U.S. Food and Drug Administration granted approval to Reblozyl (luspatercept–aamt) for the treatment of anemia (lack of red blood cells) in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.

F2G LTD: F2G Receives US FDA Breakthrough Therapy Designation for Olorofim

In Phase 2b development for the treatment of life-threatening fungal infections

FDA Health News