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 ...
Popular asthma drug Singulair could be linked to mental health side effects, suicides: FDA
Singulair, a popular asthma medication, could be linked to severe side effects, including suicide, a study from the FDA found ...
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 ...
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 ...
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 a regulatory action on bluebird bio's gene therapy for a rare ...
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 ...
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 ...
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 ...
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 ...
Every Active Food Recall Classified Highest Risk This Month
Numerous food recalls have been granted the highest warning level offered by the U.S. Food and Drug Administration ( FDA) so ...