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

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

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 ...

The draft guidance issued Tuesday comes as regulators and policymakers have looked for ways to aid U.S. drugmakers amid fast progress by their China-based counterparts.

Janux’s “masked” T cell engager had a lower response rate than reported last year. Elsewhere, Lilly dropped Zepbound’s price and ACIP named a new chairman days before a key vaccine meeting.

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

The big biotech, which has made genetic medicine a focus in recent years, is paying Tessera $150 million for rights to a ...

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

The results position Belite, one of the sector’s top-performing companies since 2022, to seek approval of what could be the ...

The startup’s lead prospect stabilizes abnormal proteins in patients with amyloid “light chain” amyloidosis, an approach that ...

The most efficient specialty pharmacies do more than maintain compliance—they act as strategic partners across the entire ...