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Investigate GLP-1 Online Marketing: Blackburn

Sen. Marsha Blackburn and Tennessee attorney general Jonathan Skrmetti call on the Federal Trade Commission to open an investigation into what they sa...

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CDER Losing Staff In Droves: Report

An online post details a significant number of resignations from CDER in the first six months of this year.

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Human Drugs

Alert on B.Braun Microbore Extension Sets

FDA issues an alert saying B. Braun Medical has notified customers recommending that certain microbore extension sets be removed from the market becau...

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Human Drugs

J&Js Bladder Cancer NDA Gets Priority Review

FDA grants priority review to Johnson & Johnsons NDA for TAR-200 for treating patients with Bacillus Calmette-Gurin-unresponsive high-risk non-muscle ...

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Human Drugs

pCR May Not be Valid Rectal Cancer Endpoint: Study

A Tulane University researcher says FDAs use of pathologic complete response as a surrogate endpoint for rectal cancer treatments is not supported by ...

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Human Drugs

FDA Looking to Expand Project Orbis Outside Oncology

FDA Oncology Center of Excellence director Richard Pazdur says the agency and its international partners are considering expanding Project Orbis from ...

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Medical Devices

Caranx AI Valve Replacement Software Cleared

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

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Human Drugs

Sandoz Recalls Mislabeled Cefazolin for Injection

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

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Medical Devices

FDA Warns Firm Marketing Blood Pressure Estimator

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

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Human Drugs

Anselamimab Trial Misses Primary Endpoint in Amyloidosis

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