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FDA Clears Ultromics EchoGo Amyloidosis Device

[ Price : $8.95]

FDA clears an Ultromics 510(k) for the EchoGo Amyloidosis for detecting cardiac amyloidosis.

Sage Ending Dalzanemdor Development

[ Price : $8.95]

Sage says it is ending dalzanemdor development in Huntingtons disease cognitive impairment following Phase 2 DIMENSION results tha...

FDA Warns Unexo Lifesciences Over CGMP

[ Price : $8.95]

FDA warns New Delhi, India-based Unexo Lifesciences about CGMP and other violations in its production of finished drugs.

FDA Finds CGMP Violations in Originitalia Inspection

[ Price : $8.95]

FDA warns Italys Originitalia about CGMP violations in its production of finished drugs.

Put Semaglutide Drugs on DDC Lists: Novo Nordisk

[ Price : $8.95]

Novo Nordisk petitions FDA to take specific steps to follow through on the companys nomination of semaglutide (Rybelsus, Ozempic, ...

CGMP Violations at Silliker Contract Lab

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FDA cautions Silliker contract testing laboratory about CGMP violations at its Gainesville, FL, facility.

Toms of Maine CGMP Issues

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FDA warns the Colgate-Palmolive Toms of Maine unit about CGMP violations in its manufacturing of finished drugs.

Cell/Gene Therapy Product Frequent Questions

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Federal Register notice: FDA makes available a draft guidance entitled Frequently Asked Questions Developing Potential Cellular a...

Jesduvroq Not Withdrawn Over Safety/Efficacy

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Federal Register notice: FDA determines that GlaxoSmithKlines Jesduvroq (daprodustat) tablets were not withdrawn due to safety or ...

Advisors Asked About Generative AI Regulation

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FDA asks members of its Digital Health Advisory Committee to spend two days discussing agency questions about its role in regulati...