The company intends to file a U.S. application in the first half of 2026 following positive study results in a condition ...

Discover why refining COAs is essential to capturing subtle, meaningful patient change—and how teams can close the ...

The deal revolves around a drug Sobi claimed could become the “therapy of choice” for people whose gout symptoms persist ...

Lilly’s closely watched retatrutide spurred as much as 29% weight loss in a Phase 3 study, a finding that is “raising the bar ...

A study using TIGIT and PD-1 drugs for gastrointestinal disease was canceled for “futility” at an early checkpoint, another ...

Using a kind of novel linker technology, the startup is developing versions of incretin and non-incretin therapies that can ...

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 ...

Hemophilia gene therapies arrived a few years ago with blockbuster expectations. But now, one therapy has been pulled from ...

The agency gave the green light to a U.S. company manufacturing Augmentin XR, an antibiotic first approved more than two ...

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 ...