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Roche says FDA approves HPV self-test in US
KFGO· 33 minutes agoBERLIN (Reuters) - Swiss drugmaker Roche on Wednesday said the US Food and Drug Administration (FDA) has approved its human papillomavirus (HPV)...
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· 11 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· 12 hours agoU.S.-listed shares of the company were down 6.6% in late afternoon trading. The health regulator...
New Clozapine Data Suggest FDA Should Ease Restrictions
Medscape· 2 hours agoThe risk for severe neutropenia with clozapine is minimal, suggesting that burdensome FDA-required hematologic monitoring should be relaxed, researchers said.
Eisai initiates rolling Biologics License Application to US FDA for Leqembi® (lecanemab-irmb) for...
FOX 5 San Diego· 4 hours agoFood and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: Leqembi) subcutaneous autoinjector for weekly maintenance dosing after it was granted Fast Track designation ...
FDA issues ‘most serious type of recall’ involving app-reliant insulin pumps
WPIX New York City, NY via Yahoo News· 20 hours agoThe U.S. Food and Drug Administration has issued a recall correction for an Apple iOS app used with...
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...
FDA Roundup: May 14, 2024
WPRI Providence· 13 hours agoOn Monday, the FDA's Office of Science and Engineering Laboratories launched an improved online Regulatory Science Tool (RST) Catalog to enhance search and browse capability ...
FDA warns users not to use Cue Health’s at-home Covid-19 tests
Medical Device Network via Yahoo Finance· 20 hours agoThe US Food and Drug Administration (FDA) has warned users not to use Cue Health’s at-home Covid-19...