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FDA Lifts Alert on Neonatal Incubators

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An FDA update says contrary to an earlier alert, all new neonatal incubators currently supplied in the U.S. do not show concerning...

AstraZenecas Calquence Wins Traditional Approval

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FDA grants AstraZeneca traditional approval for Calquence (acalabrutinib) with bendamustine and rituximab for adults with previous...

CDRH Authorized 120 Novel Devices in 2024

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CDRHs annual report says it granted marketing authorization to 120 novel devices in 2024, which was four less than the previous ye...

FDA Seeks Comments on Cannabis Use in Animals

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Federal Register notice: FDA seeks public comments on the use of cannabis-derived products (CDPs) in animals.

Commissioners Suggestions for Martin Makary

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FDA commissioner Robert Califf and three former commissioners offer their perspectives on the ways the incoming administration can...

Boehringer Schizophrenia Cognition Trial Misses Endpoints

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Boehringer Ingelheim reports disappointing data from its CONNEX clinical trial program evaluating iclepertin in cognitive impairme...

Medline Fluid Delivery Sets Recalled

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Medline Industries recalls its Medline Fluid Delivery Set with Drip Chamber because the devices were incorrectly assembled.

FDA Early Alert on Fresenius Pump Software Updates

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Citing potentially lethal risk, an FDA Early Alert says Fresenius Kabi is recommending updates to some software for its Ivenix Inf...

FDA Warns Against Using Epinephrine Nasal Solution

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An FDA alert warns healthcare professionals not to use unapproved epinephrine nasal solutions manufactured by BPI Labs and Endo US...

FDA Complete Response on Ataras Ebvallo

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FDA sends Atara Biotherapeutics a complete response letter on its BLA for Ebvallo (tabelecleucel), a monotherapy treatment for adu...