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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 metabolic disease, casting a cloud over the company's hopes for its first commercial product.
Applied Therapeutics’ NDA for govorestat receives negative response from FDA
Applied Therapeutics (APLT) announced that the FDA has issued a Complete Response Letter – CRL – for the New Drug Application – NDA – for
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 application.
Applied Therapeutics: FDA Denial Of Govorestat NDA As Problematic As It Was Unexpected
Applied Therapeutics faces challenges after FDA rejection, but future opportunities exist. Learn why APLT stock could recover with other potential approvals.
54m
on MSN
Spice Recall Issued for Nearly Every State as FDA Sets Risk Level
Curio Spice Co., a boutique spice company known for its ethically sourced and sustainably produced products, has announced a nationwide recall of its Korerima "Grains of Paradise" spice due to ...
3h
on MSN
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, ...
2d
FDA defeats lawsuit by lawyer vying to shield identity in inspection report
A judge has dismissed a lawsuit against the U.S. Food and Drug Administration by a lawyer who objected to being identified in ...
3d
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 ...
6d
on MSN
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 ...
2d
on MSN
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 ...
2h
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 ...
1d
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 ...
7d
on MSN
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 ...
JD Supra
22h
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 ...
5d
on MSN
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 ...
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