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FDA Denies Fresenius Glycopyrrolate Petition

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FDA denies Fresenius Kabis request that its glycopyrrolate solution receive a therapeutic equivalent rating with Hikmas Robinul.

Contrast Agent, Radioactive Drug, OTC Drug Status Clarified

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Attorneys James Bolani and Bonnie Odom discuss a Consolidated Appropriations Act provision that clarifies the regulatory status of...

FDA Wants RWD User Fee Funding Comments

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FDA solicits stakeholder views on external organizations that could receive real-world data funding from MDUFA 5.

Janssen Ending Mosaico HIV Vaccine Trial

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Janssen says it will discontinue its Mosaico Phase 3 trial of an HIV vaccine after a data review showed the vaccine was not effect...

Deny Mifepristone Preliminary Injunction: FDA

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FDA asks a Texas federal court to reject an Association for Hippocratic Medicine request for a preliminary injunction to overturn ...

Moderna to Seek RSV Vaccine OK

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Moderna says it will seek regulatory approval for an investigational mRNA RSV vaccine for use in older adults.

SFJ Pharma BLA for Blood Thinner Reversal Agent

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SFJ Pharmaceuticals says it has closed the sale and transfer of assets related to bentracimab from PhaseBio Pharmaceuticals, and i...

Improve HHS Oversight of Pathogen Research: GAO

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The Government Accountability Office says HHS could improve its oversight of research involving enhanced potential pandemic pathog...

CDER Continuing QMM Program Development

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The CDER Office of Pharmaceutical Quality says its two Quality Management Maturity pilots provided insights into how better to dev...

Panel to Review Isotretinoin REMS Changes

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Federal Register notice: FDA announces a 3/28-29 a joint advisory committee meeting to discuss proposed changes to the isotretinoi...