FDA, Vyloy and gastric
AbbVie Gets FDA OK for Vyalev
Nationwide Antidepressant Recall Update As FDA Sets Risk Class
The recall of the Duloxetine Delayed-Release Capsules, produced by Towa Pharmaceutical Europe, was initiated on October 10 ...
FDA asks Texas court to shut down COVID-19 vaccine records lawsuit
The U.S. Food and Drug Administration has asked a federal judge in Texas to throw out a public records lawsuit related to ...
Ex-FDA food expert reveals worst cereal in America with link to cancer
An ex-FDA employee has revealed what he claims is the most harmful breakfast cereal on the U.S. market.
BioSpace7h
FDA Pushes Back PDUFA Dates for Amgen and Intercept
The regulator has delayed its respective decision dates on whether to grant full approval to Amgen’s Lumakras in metastatic ...
Pharmaceutical Technology1h
Avadel wins FDA approval for narcolepsy drug Lumryz in children
The expanded approval intensifies the rivalry with Jazz Pharmaceuticals, which has previously attempted to block Lumryz’s ...
US FDA pauses Novavax's trial of combo COVID-flu shot on safety concerns
The U.S. Food and Drug Administration has put Novavax's trial of an experimental COVID-flu vaccine combination on hold after ...
Her breast density camouflaged her cancer. She says new FDA regulations are "a gift."
"If I have dense breast tissue, am I more prone to get cancer?" CBS News New York's Kristine Johnson asked. "The answer is, ...
Ice Cream Recall Update As FDA Sets Risk Level Over Undeclared Ingredients
The U.S. Food and Drug Administration ( FDA) has classified the recall of a brand of ice cream as Class II after it was discovered that the product contained undeclared food colorings Yellow 5 ...
medtechdive1h
Novocure wins FDA approval for electric field device in lung cancer
Alongside immunotherapy or chemo, the wearable device helped patients live longer in a trial, though the results are somewhat controversial.
FiercePharma6h
EU drug reviewers back Novo Nordisk’s FDA-rejected hemophilia drug, snub PTC’s Translarna again
After hitting a wall with the FDA last year, Novo Nordisk has picked up backing from European drug reviewers for its novel ...