A high-stakes meeting with wide-ranging public health implications again didn’t result in a vote, as members struggled to ...

Høeg, a COVID-19 vaccine critic who’s been serving as a special assistant to the commissioner, will be the fifth person this ...

FDA commissioners lambasted the CBER head’s plans to use a probe into COVID vaccine safety to upend longstanding regulatory ...

October meeting with the FDA confirm the agency doesn't see the data collected so far as enough to support an approval filing ...

Data from the "ADEPT-2" study, which analysts had hoped would arrive before year's end, are now expected sometime in 2026.

Weeks after being named head of CDER, Pazdur has submitted paperwork to step down at the end of the month, exacerbating ...

A decades-old way to bridge buyers and sellers on price, contingent value rights have recently seen an uptick in use due to a ...

Liquid biopsy offers a complementary, non-invasive alternative that expands access to testing and supports monitoring ...

Phase 3 data could make the Dutch biotech's drug competitive in the increasingly crowded market of hereditary angioedema treatments.

SciNeuro Pharmaceuticals represents the latest in a string of Arch investments directed at the nervous system, a notoriously challenging area of drug development.

Shares quadrupled now that the company appears on track to reverse an earlier FDA rejection of what could be the first ...

A deal announced Monday will see the U.K. temporarily sidestep levies on Britain-originated drugs by loosening rules that ...