FDA Related News

Coronavirus Testing Improving This Week: Gottlieb

Former FDA commissioner Scott Gottlieb says that with new approved testing coming online the U.S. will be in good shape for coronavirus testing by the...

Federal Register

FDA Gene Therapy Panel Research Update

Federal Register notice: FDA announces a 5/8 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to hear research update.

Human Drugs

Endologix PMA OKd for Abdominal Stent Graft

FDA approves an Endologix PMA Alto Abdominal Stent Graft System (Alto) for endovascular abdominal aortic aneurysm repair.

Human Drugs

Sen. Warner Wants Drug Making Moved Back to U.S

Sen. Mark Warner (D-VA) writes HHS urging it to develop a long-term plan to move pharmaceutical manufacturing back to the U.S. to reduce reliance on f...

FDA General

HHS Hit By Cyberattack to Disrupt Virus Actions

The U.S. government warns that a 3/15 cyberattack against Health and Human Services computer systems was part of a disinformation campaign designed to...

Human Drugs

FDA Lifts Clinical Hold on Unum Therapy

FDA lifts a partial clinical hold against a Unum Therapeutics Phase 1 trial involving ACTR707 in combination with rituximab in patients with CD20+ B c...

Medical Devices

Thermo Fisher Gets Fast EUA for Coronavirus Test

FDA issues the fourth coronavirus Emergency Use Authorization to Thermo Fisher for its TaqPath COVID-19 Combo Kit diagnostic.

FDA General

Since Our Last Issue ...

Industry news you may have missed since our last issue.

Human Drugs

Guide on Rare Diseases with Substrate Deposition

FDA posts a final guidance on slowly progressive, low-prevalence rare diseases with substrate deposition that result from single enzyme defects.

Medical Devices

TransEnterix 510(k) for Intelligent Surgical Unit

FDA clears a TransEnterix 510(k) for the Intelligent Surgical Unit (ISU) that enables machine vision capabilities on the Senhance Surgical System.