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 ...

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

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

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 ...

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

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

Newly launched Dayra Therapeutics has agreed to identify for Biogen "oral macrocycle candidates" that go after "high-priority ...

The company, which invested heavily in oncology in recent years, has now put more than $400 million on the table to access a ...