News Service

late-breaking news in healthcare

Contamination Rates Higher than Expected with Reusable Duodenoscopes

December 12, 2018 News Service

On December 10, 2018, the Food and Drug Administration (FDA) reported that bacterial contamination problems still persist with duodenoscopes after reprocessing, despite aggressive efforts by the agency and device manufacturers to eliminate these problems.

FDA Clears Prescription Mobile Medical App for Opioid Use Disorder

December 11, 2018 News Service

On December 10, 2018, the Food and Drug Administration (FDA) granted 510(k) clearance to reSET-O (Pear Therapeutics), a prescription mobile medical application (app) to help adults with opioid use disorder (OUD) remain in their recovery programs.

FDA News Briefs for Monday, December 10, 2018

December 10, 2018 News Service

These Food and Drug Administration (FDA) developments came in last week.

FDA Approves First-Line Tecentriq-Based Regimen for Non-Squamous NSCLC

December 7, 2018 News Service

On December 6, 2018, the Food and Drug Administration (FDA) approved a new indication for Tecentriq (atezolizumab; Genentech Inc.), an immunotherapy that targets the programmed death-ligand 1 (PD-L1) protein on cancer cells.

FDA Approves Novel Ocular Drug Delivery Device

December 4, 2018 News Service

The Food and Drug Administration (FDA) has approved Dextenza (dexamethasone ophthalmic insert) for the treatment of ocular pain following ophthalmic surgery, according to new release issued on December 3, 2018 by Ocular Therapeutix Inc.

FDA News Briefs for Monday, December 3, 2018

December 3, 2018 News Service

These Food and Drug Administration (FDA) developments came in late last week.

ASH Releases New Guidelines on Venous Thromboembolism

November 30, 2018 News Service

This week, the American Society of Hematology (ASH) released the first 6 chapters of their evidence-based clinical guidelines on venous thromboembolism (VTE). The ASH developed the new set of guidelines in partnership with the McMaster University GRADE Centre. The set will eventually include 10 chapters.

FDA Announces Plans to Revamp 510(k) Clearance Pathway

November 29, 2018 News Service

On November 26, 2018, the Food and Drug Administration (FDA) announced plans for modernizing its 510(k) clearance pathway, which dates back to 1976 and remains the agency’s main method for reviewing medical devices.

FDA News Briefs for Thursday, November 29, 2018

November 29, 2018 News Service

These Food and Drug Administration (FDA) developments came in on Wednesday.

FDA Approves New Cancer Drug for Tumor-Agnostic Indication

November 28, 2018 News Service

The Food and Drug Administration (FDA) has approved Vitrakvi (larotrectinib; Loxo Oncology), a new cancer drug for the treatment of solid tumors with a common biomarker, regardless of the location in the body where the tumor originated.