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Therapeutics, FDA
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: 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.
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.
2h
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
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 ...
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 ...
1d
on MSN
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 ...
2d
Makary for FDA. Here’s what you need to know.
President-elect Donald Trump’s Friday night news dump of health care nominees included the expected naming of Dr. Marty ...
23h
on MSN
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 ...
18h
RFK Jr. ‘very well aligned’ with FDA mission on diet-related chronic disease: fmr. FDA official
A recent slew of food recalls is raising questions about the government’s ability to ensure food safety. Former FDA official ...
1d
on MSN
Squash Recall Issued for Four States as FDA Sets Risk Level
The affected product is labeled "Squash/Sliced Zucchini and Yellow Squash" with the lot number "346918," the UPC number ...
MedPage Today
20h
FDA Investigating Blood Cancer Risk With Gene Therapy Skysona
The FDA said on Wednesday that it is investigating reports of blood cancers -- including life-threatening cases of ...
3d
FDA says it found bacteria, ‘mold-like’ substances in this popular toothpaste
Federal officials said they found black mold and disease-causing bacteria in a popular brand of toothpaste. In a letter dated ...
1d
on MSN
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 ...
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