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MR Contour DL Model Cleared for Organ Segmentation

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FDA clears a GE HealthCare 510(k) for its MR Contour DL, an artificial intelligence model that uses deep learning for organs-at-ri...

Agency Accepts Oral Wegovy NDA for Obesity

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FDA acccepts for review a Novo Nordisk NDA for a once-daily, 25 mg oral formulation of Wegovy (semaglutide) for chronic weight man...

FDA Rehiring Freedom of Information Staff

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FDA rehires some Freedom of Information office workers who were terminated under White House-mandated reduction-in-force cuts.

FDA Withdraws and Reissues 2 Guidances

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FDA says it is withdrawing two recent final guidances on cell- and tissue-based products and reissuing them in draft form to add c...

Petition Seeks to Restrict Da Vinci Off-Label Use

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A citizen petition asks FDA to restrict the off-label use of the Da Vinci Robotic System and video-assisted thoracoscopy devices t...

Placebo-controlled Trials Needed for Vaccines: HHS

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A self-described radical HHS policy now requires all new vaccines to be evaluated in placebo-controlled trials before theyre licen...

FDA Extends Aficamten Review Over REMS Request

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FDA extends by three months its review of a Cytokinetics NDA for aficamten for treating patients with obstructive hypertrophic car...

Satsuma Migraine Resubmitted NDA Approved

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FDA approves a Satsuma Pharmaceuticals 505(b)(2) NDA for Atzumi (dihydroergotamine (DHE)) nasal powder for the acute treatment of ...

Vanda Tradipitant Scheduling Order Out

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The FDA Office of Scientific Integrity publishes a scheduling order for Vandas request for a hearing on a proposed CDER order to d...

FDA Rehiring Some Travel Support Staff

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The Associated Press reports FDA is attempting to rehire some travel support, food scientist, and Freedom of Information Act staff...