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FDA, Therapeutics
Wait for galactosemia therapy goes on after FDA shuns Applied Therapeutics’ govorestat
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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: FDA Issues CRL For New Drug Application For Govorestat - Quick Facts
Applied Therapeutics (APLT) announced the FDA has issued a Complete Response Letter for the New Drug Application for govorestat, 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.
22h
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
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 ...
19h
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 ...
1d
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 ...
21h
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 ...
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 ...
MedPage Today
16h
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 ...
2d
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 ...
STAT
3d
Trump’s pick to run FDA is top exec of company that provides compounded weight-loss drugs
Martin Makary, President-elect Trump’s pick for running the Food and Drug Administration, is an executive of the telehealth ...
CNET on MSN
1d
COVID or Flu? This New FDA-Authorized, At-Home Test Will Tell You
You can now purchase a test that will tell you whether you are sick with COVID or the flu -- no prescription required.
14h
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 ...
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