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 ...
Janux’s “masked” T cell engager had a lower response rate than reported last year. Elsewhere, Lilly dropped Zepbound’s price ...
The big biotech, which has made genetic medicine a focus in recent years, is paying Tessera $150 million for rights to a ...
The draft guidance issued Tuesday comes as regulators and policymakers have looked for ways to aid U.S. drugmakers amid fast progress by their China-based counterparts.
The startup’s lead prospect stabilizes abnormal proteins in patients with amyloid “light chain” amyloidosis, an approach that ...
A deal announced Monday will see the U.K. temporarily sidestep levies on Britain-originated drugs by loosening rules that ...
The most efficient specialty pharmacies do more than maintain compliance—they act as strategic partners across the entire ...
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 layoffs affect Swiss manufacturing facilities. Elsewhere, the FDA pushed back an approval deadline and a mid-stage study ...
In a rapidly heating market, Otsuka is the first to secure FDA clearance for an "anti-APRIL" therapy targeting IgA ...