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Guardant PMA Approved for Liquid Biopsy

[ Price : $8.95]

FDA approvea a Guardant Health PMA for the Guardant360 CDx assay, the first liquid biopsy companion diagnostic that also uses next...

BD Delays Alaris Modifications 510(k) by 6 Months

[ Price : $8.95]

Becton Dickinson predicts a six-month delay in submitting a 510(k) for modifications to its troubled Alaris infusion pump.

Gilead Files NDA for Remdesivir

[ Price : $8.95]

Gilead Sciences files an NDA for Veklury (remdesivir), indicated for treating patients with Covid-19.

FDA Priority Review for Biogen/Eisai BLA for Alzheimers

[ Price : $8.95]

FDA accepts for priority review a Biogen and Eisai BLA for aducanumab, an investigational treatment for Alzheimers disease.

Draft Guide on Drug Interaction Assessments

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FDA makes available a draft guidance entitled Drug-Drug Interaction Assessment for Therapeutic Proteins.

Genentechs Spinal Muscular Atrophy Drug Approved

[ Price : $8.95]

FDA approves Genentechs Evrysdi (risdiplam) for treating spinal muscular atrophy in adults and children two months of age and olde...

FDA OKs Joimax Navigation tracking for Spinal Surgery

[ Price : $8.95]

FDA clears a Joimax PMA for its Intracs, an electromagnetic navigation tracking and control system for spinal procedures.

AbbVie Pays $24 Million Over Calif. Humira Marketing

[ Price : $8.95]

California reaches a settlement agreement with AbbVie Inc. to resolve a lawsuit alleging violations of the California Insurance Fr...

FDA OKs Dovato for Replacement HIV Regimen

[ Price : $8.95]

FDA approves ViiV Healthcares Dovato (dolutegravir/lamivudine) for treating HIV-1 infection to replace the current three-drug anti...

Majority of PMRs/PMCs On Schedule: Report

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FDA says a majority of postmarketing requirements and commitments are completed or moving toward completion on schedule.