Approval was based on improved survival outcomes vs platinum-based chemotherapy as demonstrated in the phase 3 NIAGARA study.

Received FDA authorization and recorded first commercial sales of ARC-EX SystemSecured strategic investment from Ottobock and extended cash ...

Analysts at Cantor Fitzgerald, formerly headed by the Trump administration's Secretary of Commerce Howard Lutnick, called for ...

As the Trump administration pushes to “Make America Healthy Again” and lays the groundwork for various reforms to American health care, it should set its sights on reforming the Food ...

As they readied to leave work Monday, some workers at the Food and Drug Administration were told to pack their laptops and ...

Discover how hyperbaric oxygen therapy (HBOT) works, its FDA-approved uses, emerging brain health benefits, and what to ...

Commissioner Marty Makary signed off on the plan to push out the agency’s top vaccine official, Peter Marks, in one of his ...

The FDA has long believed it has the power to regulate lab-developed tests, but it only put out the rules under former President Biden.

The forced removal was Makary’s first major act as commissioner and sent a powerful signal to a stunned Washington that was ...

The Senate has confirmed Dr Jay Bhattacharya as the new director of the NIH and Dr Marty Makary as the new commissioner of the FDA.

The U.S. Senate last week confirmed former Johns Hopkins surgeon and professor Dr. Marty Makary to lead the Food and Drug ...

The U.S. Food and Drug Administration (FDA) has released a series of announcements covering a wide range of initiatives and ...