The U.S. Food and Drug Administration on Monday proposed a new guidance for devices used to monitor blood oxygen levels to improve their accuracy and performance across a range of skin tones.

The snacks were distributed in the state of New York and have been recalled due to undeclared additives and flavor enhancers.

Snake oil, it turns out, motivated the founding of the FDA. The term “snake oil” arose out of a controversy from the late 1800s, when hucksters would sell elixirs claiming to be anti-inflammatory snake oil. Most of these products contained no snake oil and had no health benefits, sometimes even causing harm to consumers.

By the end of March, the regulator could clear a highly anticipated pain drug from Vertex and a heart drug that’s critical to Alnylam’s future.

Scott Gottlieb and Luciana Borio, a former director for medical and biodefense preparedness policy at the National Security Council,

Nuclein, a leader in rapid, point-of-care molecular diagnostics, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and a Clinical Laboratory Improvement Amendments (CLIA) waiver for its DASH® SARS-CoV-2 & Flu A/B Test for use on the DASH® Rapid PCR System.

Thousands of Americans are diagnosed every year with Parkinson’s Disease. It’s a movement disorder that affects the central nervous system. Tremor is a common symptom. The Food and Drug Administration recently approved a new drug for those living with advanced Parkinson’s.

Proper food allergen labeling can prevent costly product recalls for CPG companies, FDA representatives shared in a recent webinar.

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not

On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued a declaratory order determining that the shortage of diabetes and

The Food and Drug Administration approved Eli Lilly’s weight-loss drug Zepbound on Dec. 27 to treat sleep apnea, a common but potentially serious sleep-related breathing disorder, making it the first medication for certain patients with the condition.

Priority review granted for CUTX-101 with PDUFA target action date set for June 30, 2025 Cyprium is eligible to receive royalties and up to $129 million in aggregate development and sales milestones Cyprium also retains ownership over any Priority Review Voucher that may be issued at NDA approval MIAMI,