Steve Duffy

Digital Content Editor

Most Recent Articles by Steve Duffy

Apraglutide Gets Orphan Drug Designation for Short Bowel Syndrome

By Jan 16, 2019

The Company has already completed a Phase 1 trial of this synthetic glucagon-like peptide (GLP-2) analog.

FDA: Food Inspections to Resume Despite Ongoing Funding Lapse

By Jan 16, 2019

The news comes after FDA Commissioner Scott Gottlieb, MD announced last week a plan to recall some furloughed workers to conduct inspections.

NDA Submitted for Novel Insomnia Treatment Lemborexant

By Jan 15, 2019

The NDA includes data from two Phase 3 clinical trials (SUNRISE 1 and SUNRISE 2) which included approximately 2000 patients.

Device Approved to Treat Premature Infants With Common Heart Defect

By Jan 14, 2019

The pea-sized device is a self-expanding wire mesh that is inserted through an incision in the leg and guided through vessels to the heart, where it is placed to seal the opening.

How the Government Shutdown Affects FDA Activities

By Jan 11, 2019

The consequence of the shutdown means the budget appropriated by Congress for the Agency is on hold, resulting in ~7000 of it's 17,000 employees being furloughed.

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