GLP-1 RA Use May Up Risk for Gallbladder, Biliary Diseases
GLP-1 RA treatment linked to increased risk, especially in trials for weight loss, and with higher doses and longer duration of use
GLP-1 RA treatment linked to increased risk, especially in trials for weight loss, and with higher doses and longer duration of use
The NDA submission is supported by data from the phase 2b trial evaluating futibatinib in adults with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements.
Guideline addresses management of anticoagulants, antiplatelets during acute gastrointestinal bleeding and in the elective endoscopy setting
The phase 3 ELEVATE 12 trial evaluated the efficacy and safety of etrasimod 2mg once daily vs placebo in 354 patients.
The approval was based on data from two phase 3 induction studies and one phase 3 maintenance study.
Evidence insufficient to support a recommendation for or against screening adults, teens for eating disorders
The application is supported by data from the pivotal phase 3 PHALCON-EE trial which compared the efficacy and safety of vonoprazan to lansoprazole in patients with erosive esophagitis.
A review of regulatory and drug development status updates.
Dartisla ODT, an orally disintegrating tablet formulation of glycopyrrolate, to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer, is now available.
In the CRL, the FDA stated that a satisfactory inspection is required before the NDA can be approved.