FDA outlines plan to phase out animal testing in new draft guidance

The guidance clarifies what sponsors should consider when putting together an application for the validation of a NAM ...
JD Supra

FDA’s 2026 Guidance on General Wellness Devices: Policy for Low-Risk Devices

This three-part series reviews how the Food and Drug Administration’s (FDA) January 2026 guidance, “General Wellness: Policy for Low Risk ...

Nia Therapeutics Receives FDA Breakthrough Device Designation for AI-Guided Brain Implant to Treat Memory Loss

Nia Therapeutics announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to its Smart Neurostimulation System (SNS) for the treatment of episodic memory loss ...
MedPage Today

FDA Proposes More Flexibility in Alternatives to Animal Testing in Drug Development

Drug developers will be able to use alternatives to animal testing and possibly get new products to market faster under draft guidance issued Wednesday by the FDA. In a press release, officials said ...
Healio

FDA efforts to reduce animal testing signal shift toward AI, organ-on-chip study methods

In April 2025, the FDA announced plans to shift biomedical research for monoclonal antibodies and other medications away from animal testing toward new approaches. One year later, much speculation ...
CNBC

FDA proposes new system for approving customized drugs and therapies for rare diseases

Federal health officials on Monday laid out a proposal to spur development of customized treatments for patients with hard-to-treat diseases, including for rare genetic conditions that the ...
WPLG

FDA proposes new system for approving customized drugs and therapies for rare diseases

FDA Rare Diseases FILE - President Donald Trump listens as Dr. Marty Makary, commissioner of the Food and Drug Administration, speaks in the Roosevelt Room of the White House, Monday, Sept. 22, 2025, ...
CNN

FDA proposes new system for approving customized drugs and therapies for rare diseases

Federal health officials on Monday laid out a proposal to spur development of customized treatments for patients with hard-to-treat diseases, including for rare genetic conditions that the ...
Morningstar

Randomized Controlled Trial Demonstrated Positive Outcomes for FDA-Cleared Brain-Computer Interface IpsiHand® System in Chronic Stroke Rehabilitation

Post-market randomized study showed clinically meaningful improvement in upper extremity motor function compared to usual care VAN NUYS, Calif., Feb. 12, 2026 /PRNewswire/ -- Kandu, Inc., a healthcare ...
Nasdaq

Outset Medical Secures FDA Clearance For Next-Generation Tablo Hemodialysis System

(RTTNews) - Outset Medical, Inc. (OM) announced that the U.S. FDA has granted 510(k) clearance for its next-generation Tablo Hemodialysis System, enabling the company to introduce an upgraded platform ...
Morningstar

Global Vaccine Manufacturer Selects ValGenesis to Digitalize Equipment Qualification and Computer System Validation

ValGenesis Inc., the global leader in digital validation lifecycle management, today announced that a leading vaccine manufacturer will use its platform to digitalize and standardize equipment ...