Bylvay Approved for Progressive Familial Intrahepatic Cholestasis
Bylvay is an oral reversible inhibitor of the ileal bile acid transporter.
Gastroenterology
No Benefit From Continuous Positive Airway Pressure After Elective Major Intraperitoneal Surgery
Members of the PRISM trial group investigated whether CPAP administered immediately after major abdominal surgery could prevent postoperative morbidity.
Keytruda Indication for Advanced Gastric Cancer Withdrawn
In September 2017, the FDA granted accelerated approval to Keytruda for recurrent locally advanced or metastatic gastric or GEJ adenocarcinoma.
Upadacitinib Meets Endpoints in Ulcerative Colitis Maintenance Trial
A significantly greater proportion of patients treated with upadacitinib 15mg and 30mg achieved clinical remission at week 52 compared with those receiving placebo.
FDA to Review Vutrisiran for Polyneuropathy of Hereditary ATTR Amyloidosis
Vutrisiran is an investigational, subcutaneously-administered RNAi therapeutic designed to block the production of wild-type and mutant transthyretin protein.
Epclusa Approved for Younger Patients With Chronic Hepatitis C
The expanded approval was based on data from an open-label phase 2 trial that evaluated Epclusa in 41 patients 3 years to less than 6 years of age with chronic HCV infection.
Zeposia Approved for Moderately to Severely Active Ulcerative Colitis
The FDA has approved Zeposia® (ozanimod) for moderately to severely active ulcerative colitis in adults.
Novel Oral Therapy Fast Tracked for Reducing Postsurgical Abdominal Adhesions
LB1148 is an oral formulation of a broad spectrum serine protease inhibitor designed to neutralize the activity of digestive proteases released from the gut during surgery.
Xaracoll Implant Available for Postop Pain After Hernia Surgery
Xaracoll® (bupivacaine HCl; Innocoll Pharmaceuticals Limited) implant is now available for acute postsurgical pain relief for up to 24 hours in adults following open inguinal hernia repair. Xaracoll is a bioresorbable collagen-matrix implant designed to deliver bupivacaine HCl to the surgical site. Each implant contains 100mg of bupivacaine HCl (equivalent to 88.8mg bupivacaine) and 75mg…
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