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LDT Court Ruling As Soon As Possible, Judge Says

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The Texas federal judge hearing the consolidated cases against FDA over its final rule on laboratory-developed tests promises a ru...

Bill for Canadian Drug Imports Reintroduced

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Sens. Charles Grassley and Amy Klobuchar reintroduce legislation to provide for safe importation of drugs from Canada.

FDA Clears Ezra Flash AI

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FDA clears an Ezra 510(k) for its Ezra Flash AI model for MRI imaging.

PolarityBio Gets Breakthrough Status for SkinTE

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FDA grants PolarityBio a breakthrough therapy designation for SkinTE for treating Wagner Grade 1 diabetic foot ulcers.

2024 Device Recalls Up, Drug Recalls Down: Sedgwick

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The Sedgwick full-year recall report for 2024 shows medical device recalls increasing and drug recalls decreasing.

Becton Dickinson Recalls ChloraPrep Lot

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Becton Dickinson recalls one lot of ChloraPrep clear 1 mL applicators due to fungal contamination concerns.

Disappointing Data on Supernus Depression Drug

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Supernus Pharmaceuticals says its Phase 2b study of SPN-820 in adults with treatment-resistant depression did not demonstrate a st...

Expanded Access to TICE BCG Substitute

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FDA approves an ImmunityBIO expanded access program for recombinant BCG to help address a BCG shortage in treating bladder cancer.

What Happens to FDA in a Budget Shutdown?

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Hyman, Phelps & McNamara regulatory and medical device principal expert Richard Lewis uses his experience at FDA during the 2018-2...

AdvaMed Urges HHS Reversal of FDA Staff Cuts

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Advamed president Scott Whitaker writes HHS to urge a reversal of staff cuts at CDRH to avoid a negative impact on patient care.