FDA Related News

Medical Devices

Court Backs FDA, Medtronic in Stimulator Suits

MassDevice reports a Minnesota federal judge gave significant victories to Medtronic and FDA in four cases involving the companys spinal cord stimulat...

Human Drugs

CDER Planning 85 New, Revised Guidances

FDA publishes the latest CDER guidance agenda showing plans for 85 new or revised guidances to be issued in 2026.

Human Drugs

FDA OKs Merck's Oral PCSK9 Inhibitor for Lowering Cholesterol

FDA approves Merck's Lipfendra (enlicitide) 20 mg tablets as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol in certain ...

FDA General

Kalshi Launches Prediction Markets for Clinical Trial, FDA Outcomes

Kalshi launches a pilot program allowing traders to buy and sell contracts tied to the outcomes of late-stage clinical trials and FDA regulatory decis...

Medical Devices

Nihon Kohden Marketing Adulterated, Misbranded Devices: FDA

FDA warns Irvine, CA-based Nihon Kohden Digital Health Solutions that it is marketing an adulterated and misbranded unapproved medical device.

Human Drugs

Hearing Highlights Concerns Over Biomedical Innovation Growing in China

Witnesses at a House Energy and Commerce Health Subcommittee hearing urge lawmakers to modernize the nation's clinical trial system, and strengthen FD...

Human Drugs

House Hearing Previews Debate Over FDA Modernization, User Fees

House Energy and Commerce Health Subcommittee leaders reveal differing views over whether the Trump administration's policies are strengthening or und...

A New Era of Innovation for FDA Public Health Pillars

FDA acting commissioner Kyle Diamantas positions the agencys four public health pillars as a means to fulfill its enduring mission in a new era.

Human Drugs

VAI Close Out for HLB Inspection

A Cancer Network post says FDA issued a voluntary action indicated close-out letter to HLB following a CGMP inspection at a facility manufacturing the...

Kennedy Wanted Sentinel, BEST Data: Reuters

A Reuters deep dive into HHS secretary Robert F. Kennedy Jr.s efforts to eliminate childhood vaccine requirements says his aides asked FDA for access ...