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Revise Dietary Supplement Listing Bill: Researchers

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Harvard Medical School researchers call for major changes to dietary supplement listing proposed legislation.

Fast Track for Elevations Seribantumab

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FDA grants fast track designation for Elevation Oncologys seribantumab for the tumor-agnostic treatment of advanced solid tumors t...

inHeart 3D Cardiac Ablation Planning Software Cleared

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FDA clears an inHeart 510(k) for its inHeart Models software suite that enables 3D visualization and analysis of anatomical struct...

FDA OKs Tibsovo Expanded Use in Leukemia

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FDA approves a Servier supplemental NDA for Tibsovo (ivosidenib tablets) in combination with azacitidine for treating newly diagno...

2 Zydelig Lymphoma Indications Withdrawn

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Federal Register notice: FDA withdraws 2 Zydelig lymphoma indications that received accelerated approval because the firm failed t...

CRL for Verrica Molluscum Drug

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FDA issues a complete response letter to Verrica for its VP-102 dermatology NDA.

FDA Irresponsible in NIPT Safety Warning: Attorneys

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Three Hyman Phelps attorneys question as irresponsible FDAs decision to issue a safety communication about non-invasive prenatal t...

Former Doctor, Sales Rep Guilty in Fraud Case

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The Justice Department says a federal jury returned guilty verdicts for a former Florida pain doctor and a former Insys sales repr...

FDA De Novo for Angle Liquid Biopsy Device

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FDA grants a de novo authorization to Angle plc for its Parsortix system for use in harvesting cancer cells from metastatic breast...

Value Seen in Joint GCP Inspections

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FDA says research indicates that collaborative good clinical practice inspections by FDA and the European Medicines Agency provide...