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 ...
MedPage Today1h
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 ...
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 ...
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 ...
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 ...
MarketWatch1m
Applied Therapeutics Receives FDA Complete Response Letter for Govorestat New Drug Application
Through Wednesday's close, the stock has more-than-doubled since the beginning of the year. The FDA issues a complete response letter when it decides not to approve a new drug application in its ...
CNET on MSN10h
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.
FDA proposes removal of common decongestant
“Phenylephrine is an oral decongestant and vasoconstrictor,” Valley Health Pharmacist Dr. Aaron Stone. “By that, it means it ...
FierceBiotech8h
Outlook's stock plummets after eye drug fails to match Lucentis, but biotech still plans FDA filing
Outlook Therapeutics’ eye disease drug has failed to match Roche’s Lucentis in a key trial. The biotech brushed off the ...
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 ...
STAT2d
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 ...
Soup Recall Update as FDA Sets Highest Risk Level
A soup mix recall issued this month has been updated by the U.S. Food and Drug Administration ( FDA) as a Class I risk, the ...