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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...

Celcuity Files sNDA for Revtorpyk Expanded Use

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Celcuity files a supplemental NDA for Revtorpyk (gedatolisib) for treating certain patients with hormone receptor positive, human ...

FDA OKs RevMeds Promising Pancreatic Cancer Drug

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FDA approves Revolution Medicines Rasonque (daraxonrasib), a RAS inhibitor for the most common form of pancreatic cancer.

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...