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US FDA staff says Guardant's test may fail to detect some pre-cancerous tumors
Reuters via Yahoo News· 6 hours agoThe reviewers, however, said the test may increase compliance with screening for colorectal cancer...
FDA Finalizes Rule and Sets Course to Phase In Oversight of Laboratory Developed Tests | JD Supra
JD Supra· 12 hours agoOn May 6, 2024, following more than a decade of discourse with interested stakeholders on potential approaches to regulation of laboratory developed tests (LDTs), the U.S.
Candy, dog food, cream cheese: Here’s a list of items being recalled this month
Birmingham News· 40 minutes agoThe Food and Drug Administration and the Food Safety and Inspection Service (FSIS) have issued at...
Earnings call: BiomX reports Q1 2024 results, optimistic on phage therapies By Investing.com
Investing.com· 3 hours agoThe company's lead candidates, BX004 and BX211, are making significant progress in Phase II trials,...
FDA sets new review date for Halozyme's drug delivery tech By Investing.com
Investing.com· 2 hours agoHalozyme (NASDAQ:HALO) Therapeutics, Inc. (NASDAQ: HALO) announced that the U.S. Food and Drug...
Moderna and Novavax Hope for Early Launch of This Year’s Covid-19 Shots, Despite FDA Delay
Barrons.com· 1 day agoIn comments to Barron’s on Monday, vaccine manufacturers seemed unfazed by the delay. A Moderna...
LDTs: FDA Rolls Out a Phased Implementation for New Regulatory Requirements | JD Supra
JD Supra· 12 hours agoOn May 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final rule significantly modifying FDA’s approach ...
FDA greenlights SAB Biotherapeutics' diabetes drug trial By Investing.com
Investing.com· 3 hours agoThe U.S. Food and Drug Administration (FDA) has cleared SAB Biotherapeutics' investigational new...
New COVID-19 'FLiRT' Variants Are The Most Dominant In The U.S.
Women's Health via AOL· 2 hours agoThose who are more vulnerable to getting sick during a spring or summer surge may benefit from the...
Hims & Hers is selling an Ozempic knockoff without FDA approval. Here's how
Quartz· 57 minutes agoThe millennial-skewed telehealth platform Hims & Hers this week joined several online pharmacies in...