FDA Related News

Human Drugs

Cassiopea First-in-Class Acne Drug Approved

FDA approves a Cassiopea NDA for Winlevi (clascoterone cream 1%) for treating acne in patients 12 years and older.

Human Drugs

Teva Charged in Generic Drug Price Fixing

The Justice Department charges Teva as part of a probe into generic drug price-fixing.

Medical Devices

Braun SpaceStation MRI Cleared

FDA clears a B. Braun Medical 510(k) for the SpaceStation MRI to allow Space infusion pumps to continuously deliver medications to patients within MRI...

Medical Devices

EUA for Abbott BinaxNOW Covid Antigen Test

FDA grants an emergency use authorization for the Abbott BinaxNOW Covid-19 rapid low-cost antigen test.

Medical Devices

FDA Approves FoundationOne Liquid Biopsy Test

FDA approves Foundation Medicines FoundationOne Liquid CDx biopsy test.

Medical Devices

Public Citizen Sues FDA for Seprafilm Petition Answer

Public Citizen asks the DC federal court to compel FDA to respond to its 2015 petition asking the agency to ban Baxters Seprafilm.

Medical Devices

Mitigate Risk from IoT Vulnerability: Post

A Security Intelligence post describes an Internet of Things computer module vulnerability that could adversely affect medical devices.

Human Drugs

FDA, LUNGevity Foundation Patient Experience Study

The FDA Oncology Center of Excellence and LUNGevity Foundation launch a multi-year study of the real-world experiences of lung cancer patients.

Law Professors Voice FDA Concerns

Law professors from three universities say FDA commissioner Stephen Hahns misstatement of data supporting the convalescent plasma EUA is fueling conce...

Recalls Continue Through Pandemic: Report

Stericycle says second-quarter medical device and drug recalls remained high despite the economy shut down due to the Covid-19 pandemic.