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Noninvasive colorectal cancer screening test gains FDA approval
08 May 2024 02:45 GMT
Becker's ASC
Life sciences company Geneoscopy received FDA approval for its noninvasive colorectal …
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FDA Grants First-Ever Approval to an RNA-Based Diagnostic for Colorectal Cancer
08 May 2024 01:24 GMT
MedCity News
… Geneoscopy earned its first-ever FDA approval this week. The St … test. The test — which the FDA designated as a breakthrough device … only the second time the FDA has issued an approval for … blood in the stool, received FDA approval and became the first …
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Eating yogurt could help prevent one common disease, according to the FDA
08 May 2024 01:01 GMT
Fox News
… S. Food and Drug Administration (FDA) has implied that it’s … 'INCREDIBLY HEALTHY' The FDA intends to allow the claim … proposed qualified health claim, the FDA determined that there is some … The health claim that the FDA recently approved is referred to …
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Startup that raised over $100M gets FDA approval for cancer test
08 May 2024 00:38 GMT
The Business Journals
… colorectal cancer. Geneoscopy, with the FDA approval, said it plans to … 45 years or older. “Securing FDA approval for ColoSense marks a … billion in 2023 revenue. The FDA approval for ColoSense comes as …
- Startup that raised over $100M gets FDA approval for cancer test 08 May 2024 00:43 GMT Louis Business News - Missouri
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FDA Roundup: May 7, 2024
07 May 2024 23:55 GMT
U.S. Food and Drug Administration
… public health impact. The FDA and invited participants may … symptomatic Alzheimer’s disease. FDA and invited participants may attend … (Zoom). Today, the FDA’s Center for Biologics Evaluation … characterize clinical research. The FDA and the NIH identified …
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FDA’s latest NDI guidance falls short of goal
07 May 2024 23:39 GMT
Natural Products INSIDER
… Overview Issue. Will the FDA ever take the intellectual … industry seriously? If the FDA’s recent release of … specifics. In 2022, the FDA announced a proposed amnesty program … new NDI notification. The FDA’s earlier interpretation unnecessarily complicates …
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Outset Medical gets FDA nod for dialysis accessory months after halting sales
07 May 2024 22:47 GMT
MedTech Dive - Washington D.C.
… , Singh wrote. Outset filed an FDA submission in August. The clearance …
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Zenocutuzumab Earns FDA Priority Review in NRG1+ NSCLC, Pancreatic Cancer
07 May 2024 21:25 GMT
Cancer Network - New Jersey
… study entry. Previously, the FDA granted fast track designation … 2021.4 Additionally, the FDA granted breakthrough therapy designation to … Merus announces U.S. FDA acceptance and priority review of … #47;ydz8abrj Merus granted FDA fast track designation of …
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FDA Approves Noninvasive Stool RNA Test for Colorectal Cancer Screening
07 May 2024 21:25 GMT
Cancer Network - New Jersey
The FDA has granted approval to … in this patient population. “Securing FDA approval for ColoSense marks a … “We hope that introducing new FDA-approved diagnostic tools, including stool … of late-stage [CRC] diagnoses.” FDA approves ColoSense™ – Geneoscopy's …
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FDA Advisory Committee Will Soon Meet to Discuss MDMA-Assisted Therapy for PTSD
07 May 2024 21:23 GMT
Drug Topics
… psychedelic-assisted therapies to become FDA-approved treatments,” Rick Doblin, … 5 “We hope that potential FDA approval of MDMA-assisted … prescription.” In Depth Insights The FDA’s acceptance of Lykos’ … articles: Agony over ecstasy: FDA bid shows it’s hard …
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FDA Needs More Up-to-Date Information Before Finalizing COVID-19 Vaccines for 2024-2025
07 May 2024 21:06 GMT
Precision Vaccinations
… .S. Food and Drug Administration (FDA) today announced on X a … independent expert advice to the FDA on broad scientific topics or …
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FDA OKs First Multitarget Stool RNA Test for CRC Screening
07 May 2024 20:39 GMT
Medscape
… Food and Drug Administration (FDA) has approved ColoSense (Geneoscopy, … device designation by the FDA, detects colorectal neoplasia–associated … a news release. The FDA approval was based on … hope that introducing new FDA-approved diagnostic tools, including …
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FDA Roundup: May 7, 2024
07 May 2024 20:30 GMT
U.S. Food and Drug Administration
… public health impact. The FDA and invited participants may … symptomatic Alzheimer’s disease. FDA and invited participants may attend … (Zoom). Today, the FDA’s Center for Biologics Evaluation … characterize clinical research. The FDA and the NIH identified …
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Merus annonce l’acceptation par la FDA américaine et l’examen prioritaire de la demande de licence de produit biologique relative à Zeno dans le traitement du CPNPC et de l’ACP NRG1+
07 May 2024 20:12 GMT
GlobeNewswire, Inc.
… la Food and Drug Administration (FDA) américaine avait accepté l’examen … NRG1+. « L’acceptation par la FDA de notre première BLA constitue … Medical Oncology) 2023. La FDA a accordé à Zeno le … satisfaisantes. En outre, la FDA a accordé le statut de …
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Merus gibt Annahme und vorrangige Prüfung des Lizenzantrags für das Biologikum Zeno zur Behandlung von NRG1+ NSCLC und PDAC durch die US-Zulassungsbehörde FDA bekannt
07 May 2024 20:12 GMT
GlobeNewswire, Inc.
… bekanntgegeben, dass die US-Zulassungsbehörde FDA den Zulassungsantrag (Biologics License … ersten BLA durch die FDA ist ein bedeutender Erfolg … (ESMO) 2023 aktualisiert. Die FDA hat Zeno den Status einer … Darüber hinaus hat die FDA Zeno einen BTD für die …
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FDA sets date for advisory meeting on Lilly’s closely watched Alzheimer’s drug
07 May 2024 19:46 GMT
BioPharma Dive
… will hear presentations from both FDA staff and donanemab’s developer … questions. For example, when the FDA disclosed plans to hold an … was unexpected to learn the FDA will convene an advisory committee … on June 10, when the FDA’s Peripheral and Central Nervous …
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House Oversight chair presses FDA on China amid growing tensions
07 May 2024 19:23 GMT
Endpoints News
… (R-KY) is pressing the FDA to share more information on … biotech and other industries. The FDA’s monitoring activities in China … 14-page letter sent to FDA Commissioner Robert Califf. The letter …
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US FDA refuses more shrimp imports, including line from Choice Canning, which denies involvement
07 May 2024 18:59 GMT
SeafoodSource
… Food and Drug Administration (FDA) refused 89 seafood imports in … building gave Choice’s FDA food facility registration to … difficulty faced by the FDA in preventing antibiotic-contaminated … containing banned antibiotics by the FDA in April, 10 originated …
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Choice Canning says FDA shrimp refusals were for another Indian packer
07 May 2024 18:58 GMT
Undercurrent News
… ' Food and Drug Administration (FDA) might've identified the …
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Apple Watch gets FDA approval for use in AFib clinical studies
07 May 2024 18:36 GMT
Gizmochina
… studies, thanks to a new FDA approval. This is cherry news … States Food and Drug Administration (FDA) has approved the atrial fibrillation … that has scaled through the FDA’s Medical Device Development Tools …
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FDA Experts Weigh In On Incannex's CannQuit-O With Feedback On CBD As Treatment For Opioid Use Disorder
07 May 2024 17:13 GMT
Benzinga
… Food and Drug Administration (FDA) regarding the development of … OUD). A number of FDA representatives shared insights on the … combination of registered/FDA-approved polymers allowing for … "Feedback from the FDA on the proposed development strategy …
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What About Eli Lilly's Drug For Early Alzheimer's? FDA Panel To Discuss Next Month
07 May 2024 17:12 GMT
Benzinga
Tuesday, the FDA said it would convene an …
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FDA cracks down on companies selling CBD products
07 May 2024 17:10 GMT
dvm360
… Also this week, the FDA published a consumer update detailing … violate the law,” says FDA Principal Deputy Commissioner Amy Abernethy … forms of epilepsy. The FDA has previously sent warning letters … the release states. The FDA is encouraging human and animal …
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Hill's recall update: FDA finds systematic failure in safety procedures
07 May 2024 17:09 GMT
dvm360
… Hill's pet foods. FDA cites ‘systematic failure' in … ingredients in the future. The FDA letter states that it has … additive are considered adulterated. The FDA concludes that it was Hill … your food safety plan.” The FDA states that it cannot assess …