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Moderna Withdraws Pending BLA for Flu/Covid Vaccine

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Moderna, at FDAs urging, voluntarily withdraws a pending BLA for mRNA-1083, its flu/COVID combination vaccine candidate.

QS Violations in NeuroSync Inspection

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FDA warns Holliston, MA-based NeuroSync about Quality System regulation and other violations in its manufacturing of the Eye-Sync ...

Ethicon Endo-Surgery Recalls Surgical Stapler

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Johnson & Johnsons Ethicon Endo-Surgery recalls its Endopath Echelon Vascular White Reload for Advanced Placement Tip surgical sta...

48 New, Revised PSGs Out

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FDA publishes 34 new and 14 revised product-specific guidances to aid in generic drug development.

Miller Named Acting Inspections Chief

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FDA names Elizabeth Miller acting associate commissioner of the Office of Inspections and Investigations (OII), replacing Michael ...

FDA Warns Sarfez About Soaanz Promotional Materials

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The CDER Office of Prescription Drug Promotion warns Sarfez Pharmaceuticals that promotional materials for its Soaanz edema drug c...

Covid Vaccine Policy on Boosters and New Trials

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FDA commissioner Marty Makary and CBER director Vinay Prasad outline a new regulatory framework for annual Covid-19 booster shots...

SSRI/SNRI Labeling Changes Sought

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The Antidepressant Coalition for Education petitions FDA to change labeling for selective serotonin reuptake inhibitors and seroto...

FDA Approves Bayers Jivi Antihemophilic Factor

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FDA expands its approval of Bayers Jivi for the routine prophylactic treatment of hemophilia A in previously treated adult and ped...

Panel Wants More U.S. Patient Data on Glofitamab

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FDAs Oncologic Drugs Advisory Committee says there are insufficient number of U.S.-treated patients in a clinical trial supporting...