Casgevy, now a "national priority" drug, helped kids with sickle cell and thalassemia, results which may help toward a label ...

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

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 ...

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

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

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

After weakening an endorsement for the hepatitis B vaccine, ACIP began debating the merits of the protocol used to inoculate ...

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 ...

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