Even as the US Food and Drug Administration (FDA) has unveiled a strategic expansion of its oversight mechanisms for foreign ...

In an official filing, the company stated that it does not anticipate the warning letter will disrupt supply chains or affect ...

The US regulator has cleared use of Kerendia (finerenone) for the treatment of heart failure patients who have a left ...

Takeda is on track to submit its much-hyped narcolepsy drug to regulators this fiscal year after the orexin receptor 2 (OX2R)-selective agonist ...

Collection of ethnicity data in clinical research has been poor historically, but is essential to ensure that interventions are effective and safe across diverse populations. These data are needed to ...

Despite concerns raised by clinicians and ethicists, direct-to-consumer testing for Alzheimer’s disease biomarkers is here, ...

FDA Commissioner Marty Makary's vision for the agency risks the best of an agency that mostly has functioned well for the ...

Managed Healthcare Executive gives C-suite executives in health plans and provider organizations news and strategies for value-driven solutions.

Loss of support staff has slowed critical investigations of drug manufacturers. Little relief has materialized.

Atrioventricular interval modulation is being studied for patients with uncontrolled hypertension. Could the new technology ...

British drugmaker GSK said on Monday it had submitted an application to the U.S. Food and Drug Administration to extend the ...

The Maharashtra Food and Drug Administration (FDA) has temporarily suspended the licence of Pune's famous eatery 'Cafe ...