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CDER Commits to 11 Drug Quality Guides in 2025

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CDER posts its latest guidance agenda that shows it is committing to issuing 11 drug quality guidance documents in 2025.

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 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...

Anti-Neuropathy Guidance for Cancer Drugs

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FDA publishes a draft guidance on developing drugs to prevent and treat cancer-related chemotherapy-induced peripheral neuropathy.

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...