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Human Drugs

New Tempus Cancer Trial Service

Tempus announces its new TIME service to boost participation in cancer clinical trials.

Medical Devices

12 New NESTcc Evidence Test Cases

NESTcc says it is launching 12 new test cases to provide proof of concept for its ability to generate high-quality real-world evidence for a range of ...

Medical Devices

Letter Gives FDA Cleaning Validation Expectation: ECA

ECA Academy analyzes an FDA Warning Letter raising cleaning/disinfection issues.

Medical Devices

Hamilton Corrects Ventilator Software Over Error Message

Hamilton Medical updates all Hamilton-G5 Ventilators that contain software versions 2.60 or older to prevent the user message panel connection lost an...

Human Drugs

Lillys Emgality Approved for Cluster Headaches

FDA approves an Eli Lilly BLA for Emgality (galcanezumab-gnlm) solution for injection for treating episodic cluster headache in adults.

Human Drugs

HHS Pulls Fetal Tissue Research Funds

HHS explains its decision to stop funding research that uses fetal tissue from elective abortions.

Biologics

Enzyvant BLA for Pediatric Congenital Athymia

FDA accepts for review an Enzyvant BLA for RVT-802, a novel investigational tissue-based regenerative therapy designed to treat pediatric congenital a...

Medical Devices

Zavation 510(k) for Ti3Z Interbody System Cleared

FDA approves a Zavation 510(k) to market the Ti3Z Interbody System, a lumbar intervertebral body fusion device.

Human Drugs

Should Pfizer Have Disclosed Enbrel Alzheimers Signal?

Some scientists disagree with a Pfizer decision not to publicize research results indicating its Enbrel might be useful in preventing or slowing Alzhe...

Medical Devices

ReWalk Robotics Exo-suit for Stroke Patients

FDA clears a ReWalk Robotics 510(k) for the ReStore soft exo-suit system for use in treating stroke survivors with mobility challenges.