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Medical Devices

GE Sonic DL Image Acquirer Cleared

FDA clears a GE HealthCare 510(k) for the Sonic DL a deep learning-based technology designed to dramatically accelerate image acquisition in magnetic...

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Biologics

Ferring Gene Therapy Scale-Up Approved

FDA approves a Ferring Pharmaceuticals BLA supplement for intravesical gene therapy Adstiladrin and the companys plan to scale up its drug substance m...

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Federal Register

Guide on Contraceptive Drug Interaction Studies

Federal Register notice: FDA posts a final guidance entitled Clinical Drug Interaction Studies With Combined Oral Contraceptives.

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Federal Register

Dermatologic/Ophthalmic Drugs Panel Renewal

Federal Register notice: FDA announces the renewal of its Dermatologic and Ophthalmic Drugs Advisory Committee for an additional two years.

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Federal Register

FDA Permanently Debars Analay Rico

Federal Register notice: FDA issues an order to permanently debar Analay Rico from providing services in any capacity related to an approved or pendin...

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Human Drugs

Bipartisan Bill on Provisional FDA Approvals

A group of bipartisan senators introduce the Promising Pathway Act, a bill to help Americans with amyotrophic lateral sclerosis (ALS/Lou Gehrigs Disea...

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FDA General

FDA Needs New Policies for AI: Gottlieb

Former FDA commissioner Scott Gottlieb and his former chief of staff Lauren Silvis say FDA needs new policies geared toward integrating artificial int...

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Medical Devices

FDA Alert on Oxygenator Recall

FDA alerts health care providers and facilities on the use of oxygenators in extracorporeal circulation following a recent recall by Getinge/Maquet of...

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Human Drugs

Panel Backs Full Approval of Alzheimers Drug

An FDA advisory committee votes 6 to 0 that data from the Phase 3 CLARITY AD trial verified the clinical benefit of Eisai/Biogens Leqembi (lecanemab) ...

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Medical Devices

SurGenTec Sacroiliac Joint Fusion Device Cleared

FDA clears a SurGenTec 510(k) for its TiLink-L Sacroiliac Joint Fusion System.