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 ...
FDA approves Astellas' gastric cancer therapy
The U.S. Food and Drug Administration approved Astellas' therapy to treat a type of gastric cancer, the health regulator's ...
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 ...
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 ...
Food Safety News7h
FDA updates food import alerts for unapproved drugs, heavy metals and more
The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries.
FiercePharma16h
Astellas nabs class-first FDA approval for CLDN18.2 gastric cancer med Vyloy
After a prior rejection, Astellas can head into the weekend celebrating a class-first FDA approval for its new gastric cancer ...
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.
HealthDay on MSN2d
FDA Says Compounding Pharmacies Can Keep Making Weight-Loss Med Tirzepatide, for Now
On October 7, a compounding trade group filed a lawsuit challenging the agency's action, saying there was still a shortage of ...
BioSpace21h
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 ...
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 ...
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, ...
Novavax Says FDA Puts Clinical Hold on Covid-19, Flu Vaccines
The vaccine maker said the regulator placed the hold because of a report of a “serious adverse event” of motor neuropathy in ...