FDA rejects new drug application for surufatinib to treat advanced neuroendocrine tumors

FDA rejects new drug application for surufatinib to treat advanced neuroendocrine tumors

The FDA has informed Hutchmed Ltd. that the data package included in a new drug application for surufatinib to treat pancreatic and extra-pancreatic neuroendocrine tumors does not support approval in the U.S., the company announced.The application included results of two randomized, double-blind, phase 3 trials in China that showed efficacy and safety of surufatinib, an…

FDA grants breakthrough device designation for endoscopic ultrasound device

FDA grants breakthrough device designation for endoscopic ultrasound device

Limaca Medical announced it has received breakthrough device designation from the FDA for its Precision-GI endoscopic ultrasound biopsy device, according to a company press release.Designed to obtain tumor tissue within or bordering the gastrointestinal tract, Precision-GI features an automated, rotational cutting needle that aims to decrease sample tissue fragmentation, inadequate sample tissue amount and blood…

PPI use should be limited to appropriate indications, lowest effective dose in cirrhosis

PPI use should be limited to appropriate indications, lowest effective dose in cirrhosis

Although proton pump inhibitors were linked with an increased risk for infection and decompensation in patients with cirrhosis, they may still be of benefit in those with prior gastrointestinal bleeding, according to published data.“In this study we found that proton pump inhibitor use was associated with liver-related adverse events that may mediate liver-related mortality,” Nadim…