FDA Related News

FDAers Develop Better Poliovirus Assay

FDA scientists say they have developed a new and improved poliovirus assay.

Human Drugs

Expanded Indication for Novo Nordisks Victoza

FDA approves an expanded use for Novo Nordisks Victoza (liraglutide) for improving blood sugar control in pediatric patients with Type 2 diabetes.

Human Drugs

Lawmakers Urge Justice Dept. to Go After Generic Firms

Sen. Bernie Sanders (I-VT) and Rep. Elijah E. Cummings (D-MD) urge the Justice Department to investigate 20 generic drug manufacturers for allegedly e...

Medical Devices

Bio-Techne Prostate Test Gets 'Breakthrough'

FDA grants Bio-Techne a breakthrough device designation for its ExoDx Prostate IntelliScore test, which the company says is the first exosome-based li...

Federal Register

Industry Reps Sought for CBER Advisory Committee

Federal Register notice: FDA requests that any industry organizations interested in participating in selecting nonvoting industry representative to se...

Medical Devices

Cochlear Implant OKd for Android Smartphone Streaming

FDA approves Cochlear Limiteds new Cochlear Nucleus Profile Plus Series Cochlear Implant and the Nucleus 7 Sound Processors new built-in connectivity ...

Human Drugs

Orphan Drug Status for NuCanas Acelarin

FDA grants NuCana an orphan drug designation for its investigational drug, Acelarin (NUC-1031), and its use in treating biliary tract cancer.

Medical Devices

Cybersecurity Threat Issued on BD Alaris Gateway

Department of Homeland Securitys National Cybersecurity and Communications Integration Center issues a cybersecurity alert on BDs Alaris Gateway Works...

Human Drugs

1/2 of FDA-Required Post Marketing Studies Get Published

A just-posted article in BMC Medicine finds that about half of studies FDA requires in post-marketing commitments are ever published in peer-reviewed ...

Federal Register

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 6/14/2019.