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 ...

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 ...
STAT1d

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 ...

US FDA approves Ionis' drug for rare genetic disorder

By Sneha S K and Bageshri Banerjee (Reuters) -The U.S. Food and Drug Administration on Thursday approved Ionis ...

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 ...
Fierce Pharma1d

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 ...
Healthline1d

FDA OKs First-Ever Glucose Monitoring System for Weight Loss: What to Know

The FDA cleared the first glucose monitoring system specifically designed for weight management from Signos, providing a new ...
Medscape1d

FDA Approves New Option for Non-Cystic Fibrosis Bronchiectasis

The FDA has approved brensocatib tablets in 10-mg and 25-mg doses as once-daily treatment for non-cystic fibrosis ...

iTolerance, Inc. Appoints Former Chief of the Laboratory of Biochemistry in the FDA’s Center for Drug Evaluation and Research (CDER), Emily Shacter, Ph.D., to its Scientifi…

Esteemed expert in the regulation and development of biopharmaceuticals, with more than three decades of experience spanning ...