The FDA has accepted for review the sBLA for Afrezza (insulin human) inhalation powder in children and adolescents with type 1 or 2 diabetes.
Medtronic announced that the FDA has approved new labeling for the company’s Endurant stent graft system for use in the t ...
Denali Therapeutics has become the latest on a growing list of biotechs to experience an FDA review delay in recent months. | ...
Doctors can currently prescribe the drug only for autism off-label, which means repurposing a drug approved for one condition to treat another. "We've done the science, and the next step is that we ...
Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast ...
Washington State Backs Off Effort to Pressure Catholic Priests into Violating Seal of Confession GOP Lawmakers Demand Records on the FBI’s Attempt to Gather Phone Data on Senators Virginia School ...
A change in the safety labels on Tylenol and other acetaminophen products could be a game changer for people claiming they weren’t properly warned about possible links between the pain reliever and ...
COLUMBUS, Ohio (WCMH) — The Food and Drug Administration said it will change the labeling on acetaminophen or Tylenol, after President Trump claimed the drug can cause autism if pregnant women take it ...
The Food and Drug Administration (FDA) announced Monday it has begun the process of changing the labeling on acetaminophen to suggest that it may cause autism and ADHD in children whose mothers took ...
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