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Biologics

Janssen Ending Mosaico HIV Vaccine Trial

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

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Human Drugs

Deny Mifepristone Preliminary Injunction: FDA

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

Biologics

Moderna to Seek RSV Vaccine OK

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

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Human Drugs

SFJ Pharma BLA for Blood Thinner Reversal Agent

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

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Human Drugs

Improve HHS Oversight of Pathogen Research: GAO

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

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Human Drugs

CDER Continuing QMM Program Development

The CDER Office of Pharmaceutical Quality says its two Quality Management Maturity pilots provided insights into how better to develop and implement a...

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Federal Register

Panel to Review Isotretinoin REMS Changes

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

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Human Drugs

Stakeholder Suggestions for IHC Q5A Guidance

Two pharmaceutical associations suggest ways to clarify an International Council on Harmonization draft guidance on evaluating the viral safety of bio...

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Federal Register

FDA Permanently Debars Product Testing Lab Owner

Federal Register notice: FDA issues an order permanently debarring Gabriel J. Letizia, Jr from providing services related to an approved or pending dr...

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Federal Register

Ofirmev Not Withdrawn Due to Safety/Efficacy

Federal Register notice: FDA determines that Mallinckrodts Ofirmev (acetaminophen) injection, 1,000 mg/100 ml, was not withdrawn for safety or effecti...