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Lilly Sues 4 More Weight-Loss Drug Compounders

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Lilly sues four additional drug compounders for illegally selling copies of its weight loss and diabetes drugs.

Alert Issued on Conavis Novasight Catheters

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The catheter is part of a system intended for intravascular imaging of coronary arteries.

FDA Seeks Post-Marketing Commitment from Novavax

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Novavax says its Covid-19 vaccine BLA is being held up while FDA seeks to conclude a post-marketing commitment from the company.

CereVasc Gains Breakthrough Status for eShunt

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FDA grants CereVasc a breakthrough device designation for its investigational eShunt System and its use in treating communicating ...

ESG NextGen is Live: FDA

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FDA says its Electronic Submission Gateway Next Generation is live and ready to receive submissions.

Vanda Criticizes FDA on Tradipitant Hearing Delay

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Vanda Pharmaceuticals criticizes FDA for wrongly claiming that recent staff cuts and a new commissioner causes it to delay a compa...

Akesos Ivonescimab Meets Endpoint in Lung Cancer

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Akeso says its ivonescimab met the primary endpoint in a pivotal Phase 3 trial for the first-line treatment of advanced squamous n...

ICU Medical Illegally Marketing Devices: FDA

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FDA warns ICU Medical that its Minneapolis, MN-based Smiths Medical ASD unit is illegally marketing adulterated and misbranded inf...

CDER Continues Quality Management Program

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Federal Register notice: FDA seeks drug manufacturing establishments to participate in the second year of its voluntary Quality Ma...

FDA Integrity, Decision-Making at Risk: Blog

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FDA Matters founder Steven Grossman says FDA commissioner Martin Makary and the Trump administration are at a crossroads and need ...