News

Noodle recall update as FDA issues risk warning

The FDA classifies this recall as Class II, which the agency describes as a situation "in which use of or exposure to a ...
STAT15h

FDA says it will publish reports of adverse events tied to drugs on daily basis

The FDA said it has begun publishing reports of adverse events concerning drugs on a daily basis, instead of quarterly, as it ...

FDA Clears OTC Glucose Monitoring System for Weight Management

System integrates glucose biosensor with an AI-driven platform to show how food, activity, stress, sleep affect the body in ...

FDA Announces Recall on Over 20,000 Cans of 7Up—Here’s What to Know

FDA recalls 7Up Zero Sugar Tropical Soda for being mislabeled full-sugar soda. The affected cans were sold in 12-packs in ...

FDA approves use of animal drugs to treat New World Screwworm

The Food and Drug Administration has authorized emergency use of animal drugs to treat and prevent infestations of the New ...

Leading Researchers Reject FDA’s Position, Find No Evidence of Harm From 7-OH in Response From Shaman Botanicals to FDA

Shaman Botanicals has issued a formal response to the FDA’s recent warning letter on its 7-hydroxymitragynine (7-OH) products ...
Fierce Biotech1d

FDA accelerates Stealth Bio's rare disease application with a decision slated for next month

The FDA has accepted Stealth BioTherapeutics’ third new drug application for its ultra rare disease candidate, providing a ...
Fierce Pharma19h

Novo plant acquired in Catalent buyout faces renewed FDA scrutiny with Form 483: STAT

Despite boasting a new owner, the Indiana manufacturing plant that Novo Nordisk picked up as part of its parent company's ...

Burning issue: Lawmakers push to unblock FDA on sunscreen ingredients

With skin cancer cases up 77% since 1994, the bipartisan legislation seeks to address regulatory hurdles that have blocked ...