AI-powered medical wearables and software are flourishing following the FDA’s new hands-off regulatory guidance.

Company remains focused on potential approval and launch of IGALMI® for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting NEW HAVEN, Conn., Jan ...

Gepotidacin, a new oral antibiotic class, was approved for uncomplicated UTIs, showing noninferiority to nitrofurantoin in phase 3 trials. Semaglutide's indications expanded to include cardiovascular ...

U.S. regulators approved the first GLP-1 weight-loss pill—a tablet formulation of Novo Nordisk’s NOVO.B-2.92%decrease; red down pointing triangle Ozempic and Wegovy—ushering in a new era of the ...

The FDA approved oral semaglutide (Wegovy) for weight loss and reducing major adverse cardiovascular events. Novo Nordisk plans to launch the once-daily oral semaglutide in the US in early January ...

The US Food and Drug Administration on Monday approved a daily pill version of Novo Nordisk’s weight-loss drug Wegovy, introducing a new option for how patients can take medicines in a class of drugs ...

The FDA approved etripamil (Cardamyst) nasal spray for at-home treatment of paroxysmal supraventricular tachycardia (PSVT), maker Milestone Pharmaceuticals announced. The rapid-acting L-type calcium ...

LIB Therapeutics has scored an FDA approval for its cholesterol-lowering, third-generation PCSK9 inhibitor, lerodalcibep-liga. The injected treatment, which will carry the commercial name Lerochol, is ...

The approval marks Cardamyst as the first FDA-approved treatment in over 30 years for more than 2 million Americans with PSVT. Cardamyst nasal spray is a novel and rapid-acting calcium channel blocker ...

The U.S. Food and Drug Administration has approved Flow Neuroscience's at-home brain stimulation device to treat depression, offering an alternative to typical antidepressants that can cause side ...

Dec 11 (Reuters) - The U.S. Food and Drug Administration has approved Flow Neuroscience's at-home brain stimulation device to treat depression, offering an alternative to typical antidepressants that ...