Tuesday, December 10, 2019

Tuesday, December 10, 2019

Latest News

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.

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: 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).

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 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.

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

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

FDA Health News