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Eisai initiates rolling Biologics License Application to US FDA for Leqembi® (lecanemab-irmb) for...
FOX 59 Indianapolis· 6 hours agoFood and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: Leqembi) subcutaneous...
ENDRA Life Sciences Inc (NDRA) (Q1 2024) Earnings Call Transcript Highlights: Strategic ...
GuruFocus.com via Yahoo Finance· 2 hours agoENDRA Life Sciences Inc (NASDAQ:NDRA) is closely working with the FDA to align on clinical requirements for their TS system's de novo application, with a pre-submission meeting ...
FDA issues response to Dynavax's HEPLISAV-B sBLA By Investing.com
Investing.com· 15 hours agoDynavax (NASDAQ:DVAX) Technologies Corporation (NASDAQ: DVAX) announced today that the U.S. Food and...
FDA warns some packaged baby food contains potentially toxic metals
WFTV via Yahoo News· 19 hours agoParents with newborn babies may want to listen to this new warning from the U.S. Food and Drug...
FDA: Cue Health COVID tests may return false positive, negative results, so throw them away
Naples Daily News· 20 hours agoThe U.S. Food and Drug Administration (FDA) warned consumers and healthcare professionals Monday...
Eisai starts rolling submission for injectable version of Alzheimer's drug with US FDA
Reuters via AOL· 9 hours agoThe companies are seeking the Food and Drug Administration's (FDA) approval of a weekly dose of...
US FDA extends review of Ascendis Pharma's hormone disorder therapy
Reuters· 14 hours agoU.S.-listed shares of the company were down 6.6% in late afternoon trading. The health regulator...
QIAGEN (QGEN) Wins FDA Nod for QIAstat-Dx Respiratory Panel Plus
Zacks via Yahoo Finance· 19 hours agoQIAGEN N.V. QGEN recently secured FDA clearance for the QIAstat-Dx Respiratory Panel Plus syndromic...
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...
11 Stomach-Turning Non-Food Items The FDA Allows In Our Food
Mashed via Yahoo News· 1 day agoThe FDA allows for some surprising non-food items to get into the food supply. Here are some of the...