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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 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 dehydrogenase deficiency. Write to Josh Beckerman at
[email protected]
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
18h
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 ...
15h
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 ...
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 ...
MedPage Today
12h
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
on MSN
Exclusive: Thousands turn to Wegovy copies each month as FDA considers shortage status
More than 200,000 prescriptions for copies of Novo Nordisk's weight-loss drug Wegovy are getting filled by U.S. patients each ...
10h
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 ...
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 ...
CNET on MSN
21h
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.
12h
on MSN
FDA proposes removal of common decongestant
“Phenylephrine is an oral decongestant and vasoconstrictor,” Valley Health Pharmacist Dr. Aaron Stone. “By that, it means it ...
Washington Times
2d
Conflicts of interest at FDA must be confronted
These failures are a predictable product of the
FDA
’s culture and the leadership that Washington insiders have imposed. No ...
20h
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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