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 ...

InstantGMP categorizes software functions into low, moderate, and high process-risk groups. Low-risk features, such as equipment, room, deviation, and CAPA logs, primarily collect or tabulate data.

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 ...

ANDOVER, Mass.--(BUSINESS WIRE)--Transmural Systems, a leader in pioneering electrosurgical structural heart therapies, obtained 510(k) clearance from the United States Food and Drug Administration ...

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 ...

The EXENT System integrates immunoassay, mass spectrometry, and data review software to improve multiple myeloma diagnosis accuracy and workflow efficiency. FDA 510(k) clearance confirms the EXENT ...