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Neurotris Illegally Marketing Devices: FDA

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FDA warns Irvine, CA-based Neurotris about multiple violations in its illegal manufacturing and distribution of muscle stimulator ...

Real-Time Oncology Review Guidance

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FDA publishes a guidance with recommendations for select NDAs and BLAs submitted for Real-Time Oncology Review.

Imbria Moving Heart Drug to Phase 3

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Imbria Pharmaceuticals plans a Phase 3 study of ninerafaxstat, a novel cardiac mitotrope and partial fatty acid oxidation inhibito...

13 Brands of Sodium Chloride Irrigation USP Recalled

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Nurse Assist recalls 13 brands of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP due to the potential fo...

Bill Seeks to Shift Drug Making to U.S.

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Congresswoman Claudia Tenney (R-NY) introduces the Producing Incentives for Long-term Production of Lifesaving Supply of Medicines...

Covid Container Closure Guidance Still Effective

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FDA says a Covid-19 guidance on container closure systems is expected to be effective until 8/7/2024.

J&J Plans 2024 Surgery Robot IDE Trials

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Johnson & Johnson says it will submit an IDE in the second half of 2024 to start trials of its Ottava surgical robot.

One-Third of BTD Requests Granted: Analysis

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CDER researchers say 39% of breakthrough therapy designation requests between 2017 and 2019 were approved by FDA.

Koru Medical Prefilled Syringe Pump Cleared

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FDA clears a Koru Medical Systems 510(k) for the Freedom60 Infusion System with Hizentra 50 mL prefilled syringes.

Orphan Status for Breast Cancer Radiotherapy

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FDA grants Plus Therapeutics an orphan drug designation for rhenium obisbemeda, an injectable radiotherapy for treating breast can...