Medtronic plc’s diabetes unit posted another win with the U.S. FDA approval of the Simplera continuous glucose monitoring sensor for use with the Minimed 780G pump system, helping the company catch up ...

The U.S. FDA issued a complete response letter in October 2023 for Dupixent (dupilumab) in treating chronic hives but has now approved the monoclonal antibody for the indication. The approval makes ...

Nearly three weeks into the job, U.S. FDA Commissioner Marty Makary provided a comprehensive overview of his vision for the much-reduced agency, even as he’s taking first steps to implement his agenda ...

First quarter earnings reports from Johnson & Johnson and Abbott Laboratories provided some surprising insights into the ...

After more than three years of discussion, the World Health Organization’s Intergovernmental Negotiating Body (INB) has ...

Johnson & Johnson’s Medtech division reported the completion of the first cases in the clinical trial for the Ottava robotic ...

Genes associated with lysosomal dysfunction increase the risk of Parkinson’s disease (PD), according to a study led by ...

Nipah virus, which circulates in fruit bats and other animals primarily in Asia and the South Pacific, causes severe ...

China’s National Medical Products Administration (NMPA) has accepted Innocare Pharma Ltd.’s NDA for its second-generation pan-tropomyosin receptor kinase inhibitor, zurletrectinib (ICP-723), for ...

The recent staff cuts at the U.S. FDA’s device center caught the attention of outsiders but also caught the attention of those who work on premarket applications for 510(k) and PMA filings.

BHV-8000 from Biohaven Pharmaceuticals Inc. is a dual, brain-penetrant, oral small molecule that is highly selective against TYK2 and JAK1 enzymes, which are essential enzymes to the inflammatory ...

International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders (ADPD), researchers from Beijing Joekai Biotechnology LLC presented the discovery process and ...