FDA & Government News
The Latest
The grant rule that could reach your exam room
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by Bob Alaburda
The Office of Management and Budget proposed an overhaul of federal research funding that could halt clinical trials midstream and slow the next generation of GI treatments. Comments are due July 13.
FDA approves olezarsen to reduce acute pancreatitis risk in severe hypertriglyceridemia
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by Bob Alaburda
Tryngolza becomes the first therapy shown to lower the rate of acute pancreatitis in adults with triglycerides of at least 500 mg/dL, broadening an indication first granted for familial chylomicronemia syndrome in 2024.
FDA approves first treatment for chronic HDV
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by Doug Brunk
Phase 3 trial showed sustained viral suppression and alanine aminotransferase normalization in nearly half of treated patients.
FDA approves linerixibat for cholestatic pruritus in PBC
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by Doug Brunk
Linerixibat “is an added therapy that's mechanistically different from what we have, and therefore I think that it's going to be used."
Advances in Crohn’s disease therapies show similar safety
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by Doug Brunk
Large claims analysis finds no significant differences in serious infections, VTE, or MACE across biologics and JAK inhibitors.
FDA issues early alert for AXIOS System
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by Doug Brunk
The alert follows reports of deployment problems that may lead to serious injury, procedural complications, and even death.
Ranitidine’s return 'unlikely to provide greater clinical benefit'
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by Doug Brunk
New formulation incorporates stronger manufacturing controls and stability measures to prevent a possible carcinogen from forming.
Letter from the editor: The aftermath of Kennedy vs Braidwood
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by Megan A. Adams, MD, JD, MSc
The fight to protect science-based health policy is far from over.
An uncertain future for no-cost preventive care
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by Megan A. Adams, MD, JD, MSc
Despite a new administration, the federal government continues to advocate for upholding the law, asserting that USPSTF members are “inferior officers."
