James Jones resigned as FDA deputy commissioner and said the Trump administration's "indiscriminate" job cuts show "disdain for the very people necessary to implement your agenda." ...

As discussions intensify about how the second Trump administration will reshape the regulatory landscape for U.S.-based life sciences firms, ...

From turning away inspectors to falsifying data and leaving "bare footprints" in production containers, two of the latest ...

Globus Medical Inc. (NYSE:GMED), a leading medical device company specializing in musculoskeletal disorders, has been making waves in the healthcare sector with its recent acquisition of Nevro Corp ...

Measles doubled this week in Texas. More anti-vaccine legislation is proposed for Covid, measles, and even future outbreaks.

Elanco Animal Health (ELAN) has received a warning letter from the FDA related to promotional materials for its canine drug ...

Outset Medical (Nasdaq: OM) announced today that the FDA says it addressed all issues cited in a 2023 warning letter.

Inc. (NASDAQ:OM), a medical technology company focused on innovating dialysis treatment, has resolved all concerns raised in a Warning Letter from the U.S. Food and Drug Administration (FDA) dating ...

We are pleased to achieve this important milestone and remain vigilant as we work to continuously improve everything we do on behalf of the patients and providers we serve.” About Outset Medical, Inc.

Outset Medical (OM) said that all of the issues cited in a warning letter from the FDA in July 2023 have been addressed. Read more here.

Elanco Animal Health Incorporated issued the following statement regarding its commitment to clear veterinary and pet owner ...