FDA Related News

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.

Human Drugs

Kingston Pharma CGMP, Misbranding Violations

FDA warns Kingston Pharma about CGMP and other violations in its manufacturing of finished pharmaceuticals.

Human Drugs

Gore PMA Approved for CardioForm ASD Occluder

FDA approves a W. L. Gore PMA for the GORE CardioForm ASD Occluder for the percutaneous closure of ostium secundum atrial septal defects.

Biologics

Federal Court Rules Against U.S. Stem Cell Clinic

FDA secures summary judgment against U.S. Stem Cell Clinic for adulterating and misbranding a stem cell product not approved by FDA and failing to com...

10-Year History of Sentinel System

FDA and Harvard Medical School staff discuss the history and use of the agencys Sentinel medical product safety system.