The FDA has cleared a mobile application that will connect with a next-generation multiple daily injection automated insulin ...

BioPharma Consulting Group today announced the launch of a new digital transformation advisory framework designed to ...

On Monday, the U.S. Food and Drug Administration (FDA) approved Abbott Laboratories’ (NYSE: ABT) Volt PFA System to treat patients battling atrial fibrillation (AFib). AFib is the most common type of ...

Dr. Céline Gounder, an internist, epidemiologist and infectious disease specialist, is a CBS News medical contributor as well as senior fellow and editor-at-large for public health at KFF Health News.

Johnson & Johnson has secured an expanded indication from FDA for its TRUFILL n‑BCA Liquid Embolic System for embolization of the middle meningeal artery for the treatment of symptomatic subacute and ...

Holly™ by Nephrodite becomes the first device to achieve the designation, marking a major regulatory milestone toward first-in-human clinical studies Nephrodite, Inc., a medical device company ...

A genetic disorder that leads to bleeding episodes and life-threatening infections has a new FDA approved treatment, a regulatory decision that marks two notable firsts — the first gene therapy for ...

A new guidance document issued by the FDA this week offers recommendations for how makers of prescription biosimilars and biologic reference products should approach promotional advertising and ...

The FDA has released a plan to stop or reduce the use of primates for testing the safety of certain monoclonal antibodies (mAbs), the latest expansion of the regulator’s efforts to eliminate animal ...

O. Rose Broderick reports on the health policies and technologies that govern people with disabilities’ lives. Before coming to STAT, she worked at WNYC’s Radiolab and Scientific American, and her ...