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FDA advises against using Cue Health COVID-19 tests, sends warning letter
MedTech Dive via Yahoo Finance· 21 hours agoDive Brief: The Food and Drug Administration said Monday not to use Cue Health’s COVID-19 tests...
What Medicare beneficiaries need to know about generic medications
Fortune via Yahoo Finance· 5 hours agoWhat can make similar generics different Her experience raises the question: How can two generics...
FDA issues warning to Cue Health over COVID-19 test By Investing.com
Investing.com· 1 day agoCue Health Inc. (NASDAQ:HLTH), a healthcare technology company, has received a warning letter from...
US FDA declines to approve expanded use of Dynavax's hepatitis B vaccine
Reuters· 17 hours ago, opens new tab said on Tuesday the U.S. Food and Drug Administration (FDA) has declined to approve...
Discretion No More: FDA’s New Final Rule Regulating Laboratory Developed Tests | JD Supra
JD Supra· 24 hours agoOn April 29, 2024, the Food and Drug Administration (FDA) announced a Final Rule amending regulations to make explicit that in vitro diagnostic products (IVDs) are devices ...
FDA Warns the Parents, This Baby Milk Is Recalled And Could Be Dangerous
Dunwoody Crier· 19 hours agoFollowing guidance from the U.S. Food and Drug Administration (FDA), this Washington state-based...
FDA chides Cue Health for changing its home COVID test, tells consumers to throw them out
FierceBiotech· 15 hours agoThe FDA is recommending that anyone who still has any home COVID tests left from Cue Health should throw them away. According to the agency, its inspectors discovered that ...
FDA warns some packaged baby food contains potentially toxic metals
WFTV 9 Orlando· 17 hours agoParents with newborn babies may want to listen to this new warning from the U.S. Food and Drug...
FDA posts final guidance on remanufacturing medical devices
MedTech Dive via Yahoo Finance· 5 days agoNearly three years after publishing draft guidance, the FDA has changed the title and added a...
Syros Pharmaceuticals Inc (SYRS) (Q1 2024) Earnings Call Transcr
Guru Focus· 17 minutes agoThe FDA granted Fast Track designation for Tamibarotene in combination with venetoclax and azacitidine for the treatment of newly diagnosed unfit AML, reflecting the unmet ...