The agency considered clinical trial data showing Redemplo can significantly reduce triglyceride levels in patients with familial chylomicronemia syndrome versus placebo.

The FDA approval of the siRNA drug Redemplo caps off a tumultuous 12 months for Arrowhead, whose partnership with Sarepta caused its own stock to drop during the gene therapy maker’s safety troubles ...

Lower middle- and low-income countries are less likely to receive market authorization for drugs that were trialed within their state and approved by the FDA within 5 years of approval when compared ...

The clearance of Redemplo for a rare genetic disorder marks Arrowhead’s transition, after two decades, into a ...

Genmab's Epkinly receives traditional FDA approval for relapsed or refractory follicular lymphoma in combination and ...

Arrowhead Pharmaceuticals (ARWR) stock gains as the company wins FDA nod for lead drug Redemplo for a rare condition. Read more here.

The U.S. Food and Drug Administration approved Arrowhead Pharmaceuticals' drug for a type of genetic disorder that causes ...

Clinical data must be strong enough to exclude regression to the mean.

Cogent Biosciences has cleared another phase 3 hurdle for lead asset bezuclastinib, teeing up an approval submission for a form of gastrointestinal cancer in the first half of next year.

Background: Tricuspid regurgitation (TR) can lead to right ventricular failure (RVF) and poor clinical outcomes. The TriClip™ G4 transcatheter edge-to-edge repair (TEER) system has shown improved ...

The FDA has once again approved belantamab mafodotin (Blenrep) for multiple myeloma, 3 years after the drug left the market over questions about its efficacy. A B-cell maturation antigen ...

The US Food and Drug Administration has approved another once-a-day pill that works without hormones to treat moderate to severe hot flashes in menopausal women, drugmaker Bayer said Friday. The drug, ...