The FDA's first dedicated guidance for robotically assisted surgical devices details submission requirements across 510(k), ...

The withdrawal of the hospital antibiotic means that Merck, once strongly committed to anti-infectives, has only mature ...

Atebrioz gains US FDA approval for fibrodysplasia ossificans progressiva as the first oral therapy for the ultra-rare disease ...

Heidi Overton's FDA confirmation hearing was less about running the agency and more about navigating three political ...

Sherafat, an eight-year agency veteran, is now acting director of the Office of Therapeutic Products’ Office of Clinical ...

PhRMA, BIO and other industry groups are supporting the FDA's single-trial approval pathway, but warn its "highly persuasive" ...

FDA Commissioner-nominee Heidi Overton walked the line between backing the Trump administration and prioritizing science ...

Enveda, Basecamp Research and BigHat Biosciences raised $311m, $140m and $75m, respectively, showing investors remain ...

The GDUFA IV commitment letter tackles two of the generic industry’s persistent concerns: facilities have had no direct line ...

Can smaller markets in the EU rise to the top of launch plans by pharma companies as the US Most Favored Nation pricing ...

Among other executive moves is Bavarian Nordic recruiting a new CEO from Sanofi and Legend Biotech bringing in a new CEO from ...

The UK government has allocated £20m in funding to build regulatory science capability in areas including artificial ...