Opdivo, Bristol Myers Squibb
There was "low but improving uptake" of reporting about the diversity of participants in summary documents for FDA-cleared pulse oximeters after voluntary guidance was issued in 2013, an analysis of public FDA records found.
Initially the hair spray brand was a voluntarily recalled by CRLAB USA, based in California, on Dec. 12 and became a Class II recall by the FDA on Dec. 26.
The US Food and Drug Administration has approved the first generic referencing Victoza (liraglutide; Hikma Pharmaceuticals), a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes.
Axsome Therapeutics said it would submit its Alzheimer’s disease treatment for FDA approval despite mixed results from two new clinical trials.
In early December, the Supreme Court heard oral argument in Food and Drug Administration v. Wages and White Lion Investments, a challenge to the FDA's
Whole grains and fruits are in, and added sugar is out. That’s going to change what’s on a lot of cereal boxes and other things
A voluntary recall was initiated after it was discovered that pre-mixed Bloody Marys may contain undeclared allergens, including fish (anchovy), or soy.
BLAIR COUNTY, Pa (WJAC) — The U.S. Food and Drug Administration (FDA) has issued a temporary recall of the latest Gardners Candies' specialty candy bars. According to the announcement, the Blair County-based candy company is recalling its new "Cappuccino Meltaway" bars due to an undeclared tree nut allergen and packaging issue.
One lot of Systane Lubricant Eye Drops Ultra PF, manufactured by Alcon Laboratories, has been recalled due to fungal contamination, the FDA announced this week.
The FDA has issued a recall for specific lots of Systane eye drops due to potential fungal contamination after a consumer complaint. Users are advised to stop using the product immediately and return it for a refund or replacement.