To REMS, or not to REMS. That, apparently, was the question for Cytokinetics, which has seen any potential approval for its ...

An approval decision for Stealth BioTherapeutics’ investigational treatment for an ultra-rare genetic disease has been ...

Stealth BioTherapeutics had expected the FDA to respond on Tuesday to its marketing application for elamipretide to treat ...

The company has predicted that Imaavy — now approved for myasthenia gravis — could eventually earn more than $5 billion in ...

Medicare does not cover CBD oil, as the drug lacks FDA approval. Learn more about Medicare coverage and CBD products.

There’s new uncertainty about updated COVID-19 shots this fall after the Trump administration’s handling of a shot from ...

“It would be very disappointing if it’s not approved.” A modified version of a pill that’s been used as a smoking cessation drug in Eastern Europe for decades, cytisinicline partially ...

Former government health officials fear the Trump administration is moving to slow-walk vaccine approvals, including by ...

A new study reveals "serious adverse events" associated with mifepristone, commonly called the "abortion pill," as ...

Hardworking Tennesseans have tried changes to diets and exercise to lose weight and maintain healthy lifestyles, but ...

The plans amount to an extraordinary flex of Robert F. Kennedy Jr.’s power as health secretary to make decisions ordinarily ...

The FDA plans to gather information from 250 compounding outsourcing pharmacies amid safety and quality concerns. In a May 1 notice, the agency said it will survey outsourcing facilities about ...