Dexcom’s Stelo Glucose Biosensor system on Tuesday received the first FDA marketing clearance for an OTC continuous glucose monitor. Source: Drug Industry Daily

On Tuesday, the FDA’s Medical Imaging Drug Advisory Committee (MIDAC) green lighted Lumicell’s device-injection combo product aimed at helping surgeons detect residual breast cancer in breast tissue after lumpectomies. Source:…

Digital health technologies are uniquely effective tools for screening, diagnosing, and managing both type 1 and type 2 diabetes, according to stakeholders who commented in response to the FDA’s request…

AI models developed by GE HealthCare used readily available clinical data to forecast cancer immunotherapy outcomes and adverse reactions with 70-80 percent accuracy, according to an article published in the…

The FDA met its March 5 deadline to provide Vanda Pharmaceuticals with the details of its decision to deny the company’s request for a hearing on an sNDA for a…

President Biden announced on Monday that manufacturers for all ten drugs have agreed to participate in the Inflation Reduction Act (IRA) drug price negotiations — but that negotiations continue as…

In a likely boost to Joe Biden’s affection for Delaware, a federal judge in U.S. District Court there Friday handed a victory to the President’s much-challenged Inflation Reduction Act (IRA),…

This week, a company pares down those giant robotic surgery systems, a drug-coated angioplasty balloon opens coronary arteries with pressure and medication, an ablation system eases the pain of metastatic…

GE HealthCare subsidiary, Datex-Ohmeda’s recall of EVair and Jun-air compressors has been deemed Class I by the FDA due to potentially elevated levels of formaldehyde emissions. Source: Drug Industry Daily

During the second session of the 118th Congress, FDAnews will track pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations…