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 ...
FDA probes blood cancer risk from bluebird's gene therapy, weighs regulatory action
The U.S. Food and Drug Administration is weighing the need for regulatory action on bluebird bio's gene therapy for a rare ...
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 ...
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 ...
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 ...
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 ...
Vivek Ramaswamy’s crusade to change FDA could boost biotech, and himself
The co-leader of President-elect Donald Trump’s initiative to cut government spending has a financial stake in the biotech ...
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 ...
Trump picks Dr. Marty Makary as Food and Drug Administration commissioner
President-elect Trump announced on Friday that he is nominating Dr. Marty Makary, a Johns Hopkins School of Medicine ...
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 ...