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 ...
Targeted Oncology9h
FDA Pushes Back Decision on Sotorasib/Panitumumab in Colorectal Cancer
The FDA was expected to decide on the application of sotorasib and panitumumab for the treatment of metastatic colorectal ...
Benefits Pro12h
Can the FDA just use 'march-in rights' to make its own Wegovy?
The "takings clause" in the Fifth Amendment to the U.S. Constitution might keep the federal government from creating ...
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 ...
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 ...
BioSpace13h
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 ...
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, ...
JD Supra8h
Novacure’s Wearable Lung Cancer Treatment Device, Optune Lua, Receives FDA Approval
The FDA has granted approval for Novocure‘s wearable medical device, Optune Lua, designed to treat advanced non-small cell ...
Becker's Hospital Review12h
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 ...
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 ...