FDA Alerts

The new safety labeling changes approved by the FDA address the use of SGLT2 inhibitors prior to surgery.

The Food and Drug Administration has issued a final rule requiring new health warnings on cigarette packaging and advertisements.

The FDA has approved the first option for the treatment of patients with chronic fibrosing interstitial lung diseases with a progressive phenotype.

The new treatment is the first FDA-approved drug to address the overproduction of cortisol in Cushing disease by blocking the enzyme known as 11-beta-hydroxylase and preventing cortisol synthesis.

The Food and Drug Administration has approved the first generic pyrimethamine tablets for the treatment of toxoplasmosis to be used with sulfonamide.

The new drug is the first and only FDA-approved antiemetic for the rescue treatment of postoperative nausea and vomiting among surgical patients for whom prior standard-of-care prophylaxis was not...

The FDA has approved a new agent for lowering LDL-C in adults with heterozygous familial hypercholesterolemia or established ASCVD as an adjunct to diet and maximally tolerated statin therapy.

The US Food and Drug Administration has released laboratory results of metformin products tested for N-Nitrosodimethylamine.

The US Food and Drug Administration has approved the first drug for the treatment of allergic reactions that could occur with accidental exposure to peanuts in children.

In an interview with Gastroenterology Consultant, Mark Gromski, MD, discussed the importance of the FDA’s recent clearance of the first disposable duodenoscope and how the clearance can impact clinical...