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 ...

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 ...

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

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

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

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

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

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 ...

French startup Predict4Health SAS rebranded to Okeiro and raised €10 million (US$11.35 million).

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 ...