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.
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 ...
Injectable drug to ease advanced Parkinson's disease symptoms approved by FDA
The FDA on Thursday approved an injectable drug that eased Parkinson's disease symptoms and improved motor fluctuations in ...
BioSpace6h
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 ...
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, ...
AbbVie wins FDA nod for infusion treatment for advanced Parkinson’s disease
Vyalev is the first subcutaneous 24-hour continuous infusion of levodopa-based therapy for advanced Parkinson’s disease.
Becker's Hospital Review6h
FDA approves first heart stent designed for infants, young children
The FDA has approved the Minima stent system, the first device specifically designed for infants and young children with congenital heart defects. The innovative stent could help thousands of ...
FiercePharma5h
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 ...