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The draft guidance issued Tuesday comes as regulators and policymakers have looked for ways to aid U.S. drugmakers amid fast progress by their China-based counterparts.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

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 ...

Indiana shows high potential for the state to become the premiere destination to research, commercialize, scale biotechnology ...

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 ...

In a rapidly heating market, Otsuka is the first to secure FDA clearance for an "anti-APRIL" therapy targeting IgA ...

The second round of negotiations cuts spending an aggregate 44% over 2024 list prices as the federal government extends ...