The drugmaker presented Phase I data for the CD38xBCMAxCD3-directed trispecific at the International Myeloma Society meeting ...

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

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

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 ...

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

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

A Friends of Cancer Research paper indicated that while China has rapidly gained ground and even surpassed the US in the ...

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

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

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 ...