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Fresenius Recalls Ivenix Pump Administration Sets

[ Price : $8.95]

Fresenius Kabi recalls (Class 1) one lot of the Ivenix Large Volume Pump primary administration sets after documenting a manufactu...

Clinical Hold Lifted on Zentalis Azenosertib

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FDA removes a partial clinical hold on Zentalis Pharmaceuticals azenosertib studies into the drugs use against solid tumors and tw...

New Electronic Common Technical Document Version

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Federal Register notice: FDA announces its support for Electronic Common Technical Document Version 4.0 (v4.0)-based electronic su...

Subcutaneous Tecentriq Hybreza Approved

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FDA approves a subcutaneous injectable formulation of Genentechs Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) for all t...

FDA Corrects ANDA Approval Withdrawals from 6/21

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Federal Register notice: FDA corrects a notice that appeared in the 6/21 Federal Register announcing the approval withdrawal 20 AN...

Expanded Approval for Dupixent in Rhinosinusitis

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FDA grants expanded approval for Regeneron Pharmaceuticals and Sanofis Dupixent (dupilumab) as an add-on maintenance treatment for...

Lillys Ebglyss Approved for Eczema

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FDA approves an Eli Lilly BLA for Ebglyss (lebrikizumab-lbkz) for treating adults and children 12 years of age and older with mode...

FDA Clears SamanTrees Histolog Scanner

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FDA clears a SamanTree Medical 510(k) for its Histolog Scanner for imaging the internal microstructure of tissues including identi...

Genentechs Ocrevus Zunovo Approved for MS

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FDA approves Genentechs Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) twice-a-year subcutaneous injection for treating relap...

Senators Introduce Bill to Reduce Animal Testing

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A group of bipartisan U.S. senators introduce the FDA Modernization Act 3.0, a bill to direct the agency to finally implement the ...