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US FDA declines expanded use of Dynavax's hepatitis B vaccine on insufficient data
Reuters via AOL· 2 days agoThe Food and Drug Administration in its so-called "complete response letter" stated that the data it...
Ventilator recall issued with warning of "serious injuries or death"
Newsweek· 14 hours agoThe U.S. Food and Drug Administration (FDA) has ordered a software recall for a type of ventilator...
San Diego's Cue Health had the first FDA-approved home COVID-19 test. Now the agency says to throw...
U-T San Diego· 15 hours agoThe U.S. Food and Drug Administration told consumers Monday to throw out any at-home COVID-19 tests...
Stephen Maebius on Food and Drug Administration (FDA) | JD Supra
JD Supra· 2 days agoThis Privacy Policy describes how JD Supra, LLC ("JD Supra" or "we," "us," or "our") collects, uses and shares personal data collected from visitors to ...
FDA greenlights self-collection of vaginal samples for cervical cancer screening
CNN.com· 6 hours agoInstead of a traditional speculum-involved pelvic exam to screen for cervical cancer, the US Food ...
FDA extends review of Ascendis Pharma's hypoparathyroidism drug By Investing.com
Investing.com· 1 day agoAscendis Pharma A/S (NASDAQ:ASND), a biopharmaceutical company, has received notice from the U.S. ...
Eisai starts rolling submission for injectable version of Alzheimer's drug with US FDA
Reuters via AOL· 1 day agoThe companies are seeking the Food and Drug Administration's (FDA) approval of a weekly dose of ...
IQ-AI subsidiary wins FDA designation for lead drug candidate
Proactive Investors· 6 days agoImaging Biometrics, a subsidiary of IQ-AI Ltd (LSE:IQAI, OTCQB:IQAIF), has announced that the US ...
FDA approves self-collection screening for virus that causes cervical cancer
Anchorage Daily News· 3 hours agoThe Food and Drug Administration this week moved to expand screening for potentially lethal cervical...
FDA warns users not to use Cue Health’s at-home Covid-19 tests
Medical Device Network via Yahoo Finance· 2 days agoThe US Food and Drug Administration (FDA) has warned users not to use Cue Health’s at-home Covid ...