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Eisai initiates rolling Biologics License Application to US FDA for Leqembi® (lecanemab-irmb) for...
WROC Rochester· 5 hours agoFood and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: Leqembi) subcutaneous...
FDA: Avoid These Dairy Products During the Current Bird Flu Outbreak
Prevention· 7 days agoThe FDA reported which dairy products are safe to eat amid the recent bird flu outbreak. Bird flu...
FDA extends review of Ascendis Pharma's hypoparathyroidism drug By Investing.com
Investing.com· 13 hours agoAscendis Pharma A/S (NASDAQ:ASND), a biopharmaceutical company, has received notice from the U.S....
US FDA extends review of Ascendis Pharma's hormone disorder therapy
Reuters via AOL· 13 hours agoU.S.-listed shares of the company were down 6.6% in late afternoon trading. The health regulator...
ENDRA Life Sciences Inc (NDRA) (Q1 2024) Earnings Call Transcript Highlights: Strategic ...
GuruFocus.com via Yahoo Finance· 44 minutes 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 ...
Roche says FDA approves HPV self-test in US
Reuters via Yahoo News· 3 hours agoBERLIN (Reuters) - Swiss drugmaker Roche on Wednesday said the US Food and Drug Administration (FDA) has approved its human papillomavirus (HPV)...
FDA said it "never" inspected dental lab that made controversial AGGA device
CBS News· 2 days agoThe FDA never inspected Johns Dental Laboratories during more than a decade in which it made the...
New Clozapine Data Suggest FDA Should Ease Restrictions
Medscape· 3 hours agoThe risk for severe neutropenia with clozapine is minimal, suggesting that burdensome FDA-required hematologic monitoring should be relaxed, researchers said.
Earnings call: Liquidia Corporation eyes FDA nod for YUTREPIA By Investing.com
Investing.com· 13 hours agoLiquidia Corporation (LQDA) reported its financial results for the first quarter of 2024 and...
FDA issues ‘most serious type of recall’ involving app-reliant insulin pumps
WPIX New York City, NY via Yahoo News· 22 hours agoThe U.S. Food and Drug Administration has issued a recall correction for an Apple iOS app used with...
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