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FDA Clears Life Spine Lumbar Spacer

[ Price : $8.95]

FDA clears a Life Spine 510(k) for the Plateau-X Ti Lateral Lumbar Spacer System.

E-cig Users More Susceptible to Covid: Representative

[ Price : $8.95]

Rep. Raja Krishnamoorthi says science has demonstrated that adolescent vapers are at a higher risk of contracting Covid-19 and thu...

Becton, Dickinson Recalls ChloraPrep Applicators

[ Price : $8.95]

Becton, Dickinson recalls its ChloraPrep 3 mL applicator due to possible fungal contamination.

FDA Challenges Remestemcell-L Data

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FDA medical reviewers ask the Oncologic Drugs Advisory Committee to discuss whether Mesoblast has demonstrated that its remestemce...

Disappointing Etrolizumab Phase 3 Results

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Genentech says its etrolizumab failed to meet Phase 3 endpoints in patients with ulcerative colitis.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Taka USA and Soluciones Cosmeticas.

FDA Releases 1st Essure Adverse Event Spreadsheet

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FDA releases the first monthly spreadsheet submitted by Bayer on adverse events for its Essure birth control device.

FDA OKs Intravenous Opioid for Pain

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FDA approves a Trevena NDA for Olinvyk (oliceridine), an opioid agonist for managing moderate to severe acute pain in adults.

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

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