US FDA declines to approve Applied Therapeutics' genetic disease drug
Applied Therapeutics said on Wednesday that the U.S. FDA declined to approve its drug to treat galactosemia, a rare genetic ...
Carrots, ice cream and more items recalled by the FDA. Here's the list for November 2024
Here's a list of what was pulled from stores in November 2024. The FDA removed the following items from store shelves in ...
Soup Recall Update as FDA Sets Highest Risk Level
A soup mix recall issued this month has been updated by the U.S. Food and Drug Administration ( FDA) as a Class I risk, the ...
FDA Expands Carrot Recall Linked to E. Coli: 39 Illnesses, 15 Hospitalizations Reported
The FDA expanded the recall on November 21 after 39 cases of illness, resulting in 15 hospitalizations and one death, have ...
Applied Therapeutics Down 76% After Hours on FDA Complete Response Letter
An FDA complete response letter indicates that an application can't be approved in its current form. Govorestat, the company's lead drug candidate, is also being developed for treatment of sorbitol ...
FDA proposes removal of common decongestant
“Phenylephrine is an oral decongestant and vasoconstrictor,” Valley Health Pharmacist Dr. Aaron Stone. “By that, it means it ...
Are food recalls and outbreaks on the rise? FDA says U.S. food supply still "one of the safest in the world"
The FDA says America's food supply is still "one of the safest in the world," despite some recent high-profile recalls and ...
What The FDA Gets Wrong About Drug Ads
Regulators need to know that our most important health care problem is not that people are taking too many prescription drugs ...
Applied Therapeutics Receives FDA Complete Response Letter for Govorestat New Drug Application
Applied Therapeutics said it has received a complete response letter from the Food and Drug Administration related to its new drug application for govorestat due to deficiencies in the clinical ...
Still shopping for Thanksgiving? Here are 5 food items that were recalled by the FDA
The FDA and the United States Department of Agriculture are currently investigating several food items due to illness ...
JD Supra3h
FDA Provides Perspective on Goals and Challenges for Regulation of Artificial Intelligence in Medical Devices, Drug Design, and Clinical Research
A recent article authored by Haider J. Warraich, MD; Troy Tazbaz; and Robert M. Califf, MD in the Journal of the American ...
Seafood Recall Update As FDA Sets Risk Level
The seafood salad may be of particular risk to those customers who have an allergy or severe sensitivity to soy, the FDA has ...