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HHS to Appoint 2 New FDA Deputy Commissioners: CNBC

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CNBC reports that HHS plans to appoint two new FDA deputy commissioners in hopes of exerting more influence over the agency.

Boston Scientific ENROUTE System Recall is Class 1

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FDA says the Boston Scientific recall of its ENROUTE Transcarotid Neuroprotection System is Class 1.

Do More to Capture Nonprescription Drug Use Info: Meeting

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Participants in a 4/23 FDA meeting on increasing access to nonprescription drugs see a need to improve the electronic health recor...

Osfamide Shortage Seen

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An oncology physician association says its members are reporting a shortage of the chemotherapy agent ifosfamide for which no dire...

FDA Issues Alert on Abiomed Impella Controllers

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CDRH issues an early alert to notify the public about an Abiomed action recommending that all Automated Impella Controllers be rem...

Petition Seeks Carbetocin OK for Postpartum Hemorrhage

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Two physicians affiliated with Stanford Universitys medical school urge FDA to approve carbetocin for preventing postpartum hemorr...

Jemperli sBLA for Rectal Cancer Accepted for Priority Review

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FDA accepts for priority review a GSK supplemental BLA for Jemperli (dostarlimab) for certain patients with previously untreated S...

Comments on Expedited IND Pilot

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Three stakeholders provide their responses to an FDA Request for Information on the Operation TrialBlazer Expedited IND Pilot Proj...

Device, Drug Recalls Down, Units Up

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The Sedgwick Recall Index shows that in the first half of 2026, medical device and drug recalls fell, but the number of recalled u...

Wearable Device Monitors Ketone Levels and Blood Sugar

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FDA grants Abbott Diabetes Care a de novo authorization for the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System ...