FDA
FDA Issues Serious Liver Injury Warning for Obeticholic Acid
The FDA has issued a warning of serious liver injury for patients taking obeticholic acid for primary biliary ...
JANUARY 21, 2025
FDA Grants Breakthrough Device Designation to New Sepsis Test
The FDA has granted Breakthrough Device designation to a new rapid diagnostic blood test for sepsis (MeMed ...
JANUARY 17, 2025
FDA Expands Indication to BE for Magnetic Sphincter Augmentation Device
The FDA has expanded the indication for the magnetic sphincter augmentation device LINX to encompass patients with ...
AUGUST 23, 2024
FDA Approves Risankizumab for Ulcerative Colitis
The FDA has approved risankizumab (Skyrizi, AbbVie) for patients with moderate to severe ulcerative colitis.
JULY 8, 2024
The Long Journey to FDA Approval for OTC Naloxone
Efforts to increase access to naloxone—even for harm reduction programs—were still meeting distribution ...
MAY 8, 2023
Reports of Endoscope Contamination Rose Significantly Since 2014, New Analysis Says
Adverse event reports submitted to the FDA, describing the actual or potential contamination of a reprocessed ...
SEPTEMBER 1, 2022
FDA Response to Surgical Stapler Safety Article
The internal staplers of 2020 are very different technologically than the staplers used prior to 1990. This is ...
JULY 22, 2020
Identifying the Root Cause of Drug Shortages
How could drug shortages happen in a free enterprise country like the United States?
JANUARY 20, 2019
FDA Bans Powdered Medical Gloves in Surgery
The FDAs proposed ban on powdered medical gloves took effect on January 18. The gloves were found to pose an ...
JANUARY 26, 2017
FDA Recommends Universal Testing of U.S. Blood Supply for Zika Virus
About 1 million blood donations are collected in the U.S. every day.
AUGUST 26, 2016
FDA Advisory Panel Gives Nod to Zinplava for Treatment of C. Diff
The monoclonal antibody, which is not an antibiotic, binds to the C. difficile toxin B.
JUNE 29, 2016
Device Recalls Surge in Recent Years, Prompting Question: Why?
The FDA approves or clears thousands of new medical devices each year. This highly complex process of review has ...
APRIL 12, 2016