FDA clears the Samsung Wellysis units wearable electrocardiography patch, S-Patch Ex.
The White House credits FDA actions in helping to reduce cancer drug shortages.
Abbott recalls its Proclaim and Infinity implantable pulse generators due to complaints from patients who are unable to exit MRI mode.
FDA accepts for priority review a Madrigal Pharmaceuticals NDA for resmetirom and its use in treating adult patients with nonalcoholic steatohepatitis...
Federal Register notice: FDA determines that Gemini Laboratories Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, were withdrawn from sale for reason...
Pharmaceutical Research and Manufacturers of America says FDA should take a more flexible approach to determining good cause for failing to meet postm...
Bipartisan lawmakers introduce legislation in the Senate and House to close a patent-listing loophole that drug manufacturers use to extend their excl...
An FDA advisory committee votes 9 to 3 that the benefits of Alnylam Pharmaceuticals patisiran (Onpattro) outweigh its risks for treating cardiomyopath...
