Sunday, December 8, 2019

Sunday, December 8, 2019

Latest News

AMERICAN SOCIETY OF HEMATOLOGY: ASH and FDA Unveil New Recommendations to Guide Clinical Development of Sickle Cell Disease Therapies

Joint FDA/ASH Led Initiative Highlights Importance of Using Patient Reported Outcomes and Biomarkers in Clinical Trials to Advance SCD Therapies

U.S. FDA: Sends warning to companies for offering unapproved umbilical cord blood products that may put patients at risk

Liveyon Labs Inc. and Liveyon LLC warned that their stem cell products lack required FDA approval and represent a potential risk to the public health

U.S. FDA: FDA launches app for health care professionals to report novel uses of existing medicines for patients with difficult-to-treat infectious diseases

The U.S. Food and Drug Administration today announced the global launch of CURE ID, an internet-based repository that will allow the clinical community to report their experiences treating difficult-to-treat infectious diseases with novel uses of existing FDA-approved drugs through a website, a smartphone or other mobile device.

SK LIFE SCIENCE, INC.: Announces FDA Acceptance of IND Application for Anti-Epileptic Drug Candidate SKL24741

Acceptance of the IND application will allow the company to begin Phase I clinical trials for SKL24741 in 2020

U.S. FDA: FDA approves system for the delivery of ear tubes under local anesthesia to treat ear infection

The U.S. Food and Drug Administration approved a new system for the delivery of tympanostomy tubes, commonly referred to as ear tubes, that can be inserted into the eardrum to treat recurrent ear infections (i.e., otitis media).

U.S. FDA: FDA approves novel treatment to target abnormality in sickle cell disease

The U.S. Food and Drug Administration granted accelerated approval to Oxbryta (voxelotor) for the treatment of sickle cell disease (SCD) in adults and pediatric patients 12 years of age and older.

U.S. FDA: Statement on efforts to help make development of biosimilar and interchangeable insulin products more efficient

Access to affordable insulin can be a matter of life and death for Americans with diabetes. If not appropriately treated, diabetes can lead to serious and life-threatening complications, including heart disease, organ failure and blindness.

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

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

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.

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.

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

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

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

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.

FDA Health News