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Biologics

RFK Jr. Ignores Hill Request on Anti-Vax Activist HHS Role

HHS secretary Robert F. Kennedy Jr. faces renewed scrutiny from Senate Democrats for ignoring requests about the role of longtime anti-vaccine activis...

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Human Drugs

Lilly Says Retatrutide Delivered Up to 30% Weight Loss

Eli Lilly reports that its investigational obesity drug retatrutide produced weight-loss results approaching those historically associated with bariat...

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Biologics

FDA to Convene Panel on Modernas mRNA Flu Vaccine

FDA announces a 6/18 advisory committee meeting to review Modernas controversial mRNA-based seasonal influenza vaccine.

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Human Drugs

Clarity Sought on FDA New Approach Methodologies Guide

Stakeholders suggest ways FDA could clarify a draft guidance on using new approach methodologies in drug development.

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Human Drugs

Comments on Increasing Access to Non-Prescription Drugs

Four stakeholders comment to FDA on ways to increase patient access to nonprescription drugs.

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Medical Devices

Bolton Thoracic Stent Recall is Class 1: FDA

FDA says a Bolton Medical recall of its RelayPro thoracic stent graft system is Class 1.

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Human Drugs

Clinical Electronic Structured Protocol Template

FDA publishes for reference only an International Council for Harmonization template on a clinical electronic structured harmonized protocol.

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Medical Devices

React Health Recalls Ventilators Due to Manufacturing Issue

React Health recalls certain VOCSN V+Pro ventilators due to a manufacturing issue that could lead to undetected oxygen leaks and potentially cause ser...

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Human Drugs

All India Institute Clinical Trial Issues

FDA warns Dr. Sourav Mishra about violations in his conduct of a clinical investigation at the All India Institute of Medical Sciences in Bhubaneswar,...

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Human Drugs

Naseem Jaffrani BIMO Violation

FDA warns Alexandria, LA-based cardiologist Naseem Jaffrani about his failure to conduct a clinical investigation according to the investigational pla...