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US FDA declines Moderna flu vaccine review amid vaccine guidance rollback
CEO Stephane Bancel said the letter refusing review did not cite 'any safety or efficacy concerns'.
Merck’s cholesterol pill gets US FDA approval
Merck said on Thursday the U.S. FDA has approved its cholesterol pill, the first of its kind to receive the health regulator’s nod, bolstering the drugmaker’s efforts to diversify beyond its blockbuster cancer treatment Keytruda.
Galaxy Watch blood pressure monitoring isn’t approved by the US FDA
Samsung has confirmed that the Galaxy Watch blood pressure monitoring feature doesn't require approval from the FDA in the US.
US FDA to limit regulation of health and fitness wearables, commissioner says
The U.S. Food and Drug Administration said on Tuesday that it will limit regulation of wearable devices and software designed to support healthy lifestyles, issuing new guidance to clarify its regulatory approach.
US FDA proposes using existing science to speed up gene therapy development
The U.S. Food and Drug Administration on Tuesday proposed allowing makers of cell and gene therapies targeting rare and life-threatening diseases to use existing scientific knowledge to expedite development.