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Web Site Selling Essential Oils as Covid Treatment: FDA, FTC

FDA and FTC say the Web site organic-beauty-recipes.com is promoting essential oils that claim to prevent, treat, or cure Covid-19 as an Amazon Associ...

Human Drugs

Curis Gets FDA Go Ahead for Anti-Vista Antibody

FDA approves a Curis IND application for CI-8993, which it describes as the first-in-class monoclonal anti-Vista antibody, for a Phase 1a/1b study of ...

Human Drugs

FDA Clears 4Web Lumbar Interbody Fusion Device

FDA clears a 4Web Medical 510(k) to market its Stand-Alone Anterior Lumbar Interbody Fusion Device.

Human Drugs

CURE ID Updated for Better Covid Use

FDA and the National Center for Advancing Translational Sciences say they have updated the CURE ID app to make it easier for doctors to enter Covid-19...

Human Drugs

More FDA Covid Transparency Needed: Professor

A University of Minnesota professor says FDA should be much more transparent about how its Coronavirus Treatment Acceleration Program works.

Human Drugs

AbbVie, Genmab Collaborate on Cancer Antibody Therapies

AbbVie and Genmab announce a collaboration agreement to jointly develop and commercialize three of Genmabs early-stage investigational bispecific anti...

Medical Devices

EUA for Covid Next-Generation Sequencing Test

FDA grants an emergency use authorization for the Illumina COVIDSeq test using next-generation sequencing technology.

Biologics

International Regulators Working on Covid Vaccine: Marks

CBER director Peter Marks says FDA is working with health regulators in other countries to reach broad agreement on parameters of clinical trials for ...

Medical Devices

New Rad Health Email Reporting Available

FDA says that all radiation safety reports may now be submitted to CDRH by email to the RadHealthCustomerService@fda.hhs.gov mailbox.

Medical Devices

Atomic Blue UV-C Germicidal Light Cleared

FDA clears an Atomic Blue 510(k) for its high-performance UV-C germicidal light for commercial use in eradicating the Covid-19 virus from surfaces.