The FDA already contracts with 43 states and Puerto Rico to do some routine inspections. States have handled about one-third ...

The FDA had rejected the companies’ initial application in 2023, requesting additional data after the pharma firms reported ...

President Donald Trump signed an Executive Order (EO) titled “Lowering Drug Prices by Once Again Putting Americans First,” outlining ...

For companies in the biotech space, it’s never been easy to navigate the legal and business risks inherent in a highly ...

The FDA’s Breakthrough Device Designation represents a key milestone for Orchestra BioMed as it continues to work closely with the FDA, Medtronic, and the clinical community to maximize the impact of ...

Breakthrough Device Designation ("BDD”) applies to an estimated U.S. population of over 7.7 million patients with uncontrolled hypertension and increased cardiovascular risk BDD also encompasses ...

President Trump issued an executive order titled “Lowering Drug Prices by Once Again Putting Americans First.” The order ...

Breakthrough Device Designation ("BDD") applies to an estimated U.S. population of over 7.7 million patients with uncontrolled hypertension and increased cardiovascular riskBDD also encompasses pacema ...

Independence Health Group, the parent company of Independence Blue Cross, spent $500 million last year to provide ...

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced a significant expansion of its manufacturing capacity through a ...

Healthcare is ever-changing, as it has been for decades. Sometimes, these changes are for the better, while other times, they may be for the worse. Becker’s connected with several physicians across a ...

KENNEDY, in interview with Sean Hannity that aired on Fox News on March 11: “There are adverse events from the vaccine. It ...