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FDA AI Moves Raise Questions: Attorneys

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Three Akin attorneys say regulated industry continues to have questions about FDA actions in launching an internal artificial inte...

Panel Votes Down GSK Multiple Myeloma Drug

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FDAs Oncologic Drugs Advisory Committee votes against approving GSKs BLA for Blenrep (belantamab mafodotin) for treating adults wi...

Dexcom Recalls Dexcom Glucose Monitor Receivers

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Dexcom recalls certain Dexcom G6, G7, ONE, and ONE+ glucose monitoring receivers because a speaker problem may prevent an alert fr...

Investigate GLP-1 Online Marketing: Blackburn

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Sen. Marsha Blackburn and Tennessee attorney general Jonathan Skrmetti call on the Federal Trade Commission to open an investigati...

Caranx AI Valve Replacement Software Cleared

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FDA clears a Caranx Medical 510(k) for its TaviPilot Soft, which the company describes as AI software for real-time intra-operativ...

Sandoz Recalls Mislabeled Cefazolin for Injection

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Sandoz expands a 6/25 recall of cefazolin for injection to include one additional lot after the company received a customer compla...

FDA Warns Firm Marketing Blood Pressure Estimator

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FDA warns Boston, MA-based Whoop that it is illegally marketing an unapproved medical device that estimates blood pressure, despit...

Anselamimab Trial Misses Primary Endpoint in Amyloidosis

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A Phase 3 clinical trial evaluating Alexions anselamimab for light chain amyloidosis fails to meet its primary endpoint, but shows...

New Orphan Product Grant Funding Opportunity

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FDA releases a funding opportunity for natural history studies to advance product development in rare diseases and conditions.

7 Observations in Natco Pharma FDA-483

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FDA releases the form FDA-483 with seven observations from an inspection at Indias Natco Pharma.