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Glaxos Boostrix OKd for Unborn in Third Trimester

[ Price : $8.95]

FDA approves GlaxoSimthKline Biologicals Boostrix vaccine to immunize, during the third trimester, unborn children against pertuss...

FDA Proposal to Destroy Devices Refused U.S. Entry

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Federal Register proposed rule: FDA proposes a regulation to implement its new authority to destroy a device valued at $2,500 or l...

Biosimilar User Fee Rates Set for FY 2023

[ Price : $8.95]

Federal Register notice: FDA announces the rates for biosimilar user fees for fiscal year 2023.

FDA Issues Abbott EUA for Monkeypox Test

[ Price : $8.95]

FDA issues Abbott Molecular an emergency use authorization for its Alinity m MPXV and its use in detecting the monkeypox virus.

Alnylam Gains Expanded Label for Oxlumo

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FDA approves an Alnylam Pharmaceuticals supplemental NDA to expand the label for Oxlumo (lumasiran).

FDA Wants Makena Withdrawn While New Trial Conducted

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In arguing for its market withdrawal, an FDA briefing document says Covis Makena is not effective and has known risks.

Fresenius Recalls Ivenix Infusion Pump

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Fresenius Kabi recalls its Ivenix Infusion Systems large volume pump software due to a software design issue.

FDA Steps to Harmonize with HHS Common Rule

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Two FDA officials describe steps the agency is taking to harmonize its oversight of clinical trials with the HHS Common Rule on pr...

Ways to Improve FAERS Signal Review

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Yale University researchers say FDA should consider three ways to enhance the timely and robust assessment of drug safety signals ...

Boston Cell Standards IHControls Panel Cleared

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FDA clears a Boston Cell Standards 510(k) for its IHControls panel (HER2/ER/PR) for evaluating breast cancers.