FDA Update & Product News
Wegovy Approved to Treat MASH With Moderate to Advanced Fibrosis
The FDA has approved semaglutide in conjunction with diet and exercise for the treatment of MASH with moderate to advanced fibrosis.
AUGUST 20, 2025
Recall Issued for Some Esophageal pH Monitoring Capsules
The FDA issued an alert following device manufacturer Medtronic’s announcement recommending that certain Bravo calibration-free capsule delivery devices be quarantined from sale or use.
JULY 8, 2025
FDA Approves Expanded Indication for Mavyret for Acute HCV
The FDA expanded the indication for Mavyret to treat adults and pediatric patients 36 months of age and older with acute or chronic HCV without cirrhosis or with compensated cirrhosis.
JULY 2, 2025
Alert Issued for Some Olympus AERs Manufactured in Japan
The FDA has issued an alert regarding automated endoscope reprocessors manufactured by Olympus in Japan and has banned future shipments of these devices from entering the United States.
JULY 1, 2025
FDA Approves Checkpoint Inhibitor Combination For Unresectable or Metastatic HCC
The FDA has approved nivolumab with ipilimumab for the first-line treatment of adults with unresectable or metastatic hepatocellular carcinoma.
JUNE 11, 2025
FDA Approves Zynyz for Squamous Cell Carcinoma of the Anal Canal
The FDA approved retifanlimab with carboplatin and paclitaxel for the 1L treatment of adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC).
MAY 26, 2025
FDA Approves Opdivo With Yervoy for Unresectable or Metastatic Hepatocellular Carcinoma
The FDA has approved nivolumab (Opdivo, Bristol Myers Squibb) with ipilimumab (Yervoy, Bristol Myers Squibb) for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma.
APRIL 23, 2025
FDA Approves Opdivo With Yervoy for Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer
The FDA has approved nivolumab with ipilimumab for adult and pediatric patients 12 years of age and older with unresectable or metastatic microsatellite instability−high or mismatch repair−deficient colorectal cancer.
APRIL 16, 2025
FDA Authorizes Marketing for Novel Endoscope Cleaner
The FDA recently authorized marketing for the CORIS system, an endoscope channel cleaner that uses a proprietary agent to clean channels in the Olympus EVIS EXERA III CF-HQ190L colonovideoscope.
APRIL 9, 2025
New Double Balloon Endoscope Now Commercially Available
A new double balloon endoscope, EN-840T, is now commercially available in the United States, device manufacturer Fujifilm has announced.
APRIL 3, 2025
FDA Approves Cabometyx for pNET and epNET
The FDA granted approval for cabozantinib for patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumor and well-differentiated extra-pancreatic neuroendocrine tumor.
MARCH 31, 2025
Keytruda Receives Traditional Approval for Some Patients With HER2-Positive Gastric or GEJ Adenocarcinoma
The FDA has approved pembrolizumab with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
MARCH 28, 2025