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 ...
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 ...
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 ...
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 ...
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 ...
Exclusive: US FDA finds widely used asthma drug impacts the brain
U.S. government researchers have found that a widely prescribed asthma drug originally sold by Merck & Co may be linked to ...
A Popular Asthma Drug May Be Causing Brain Damage
New data collected by the FDA has found that montelukast can bind to brain cells, which may explain the risk of mental health ...
RFK Jr. weighing FDA crackdown on food additives under Trump
Kennedy Jr. are weighing a significant rewrite to the Food and Drug Administration's rules governing food additives, to ...
US FDA approves BridgeBio's drug for rare heart condition
The U.S. Food and Drug Administration has approved BridgeBio's drug for a rare and deadly heart condition, the company said ...
The FDA cracked down on sweet vapes after kids’ use spiked. Now, Supreme Court wades in
Vaping is coming before the Supreme Court next week as federal regulators ask the high court to uphold its block on sweet, ...
JD Supra19h
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 ...
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 ...