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Guide on Clinical Trials Using Tissue Biopsies

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FDA posts a draft guidance entitled Considerations for Including Tissue Biopsies in Clinical Trials.

Draft Guide on Using AI for Drug Development

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FDA releases a draft guidance entitled Considerations for the Use of Artificial Intelligence (AI) to Support Regulatory Decision-M...

Neumoras Phase 3 Depression Study Misses Endpoints

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Neumora Therapeutics says its Phase 3 KOASTAL-1 Study of navacaprant for treating major depressive disorder missed its primary end...

CDER Approved 50 Novel Products Last Year

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CDER approves 50 novel products in 2024, five less than the 55 products approved in 2023 and well above the 10-year rolling annual...

FDA OKs Galderma Dermatitis Drug Nemluvio

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FDA approves Galdermas Nemluvio to treat some dermatitis patients aged 12 and older.

Alcon Recalls Systane Ultra PF Eye Drops

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FDA says Alcon recalled one lot of Systane Ultra PF eye drops due to potential fungal contamination.

FDA OKs Arrays Braftovi for Some Cancers

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FDA approves Array BioPharmas Braftovi to treat some patients with metastatic colorectal cancer with a specific mutation.

QS, MDR Violations at Rontis Hellas in Greece

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FDA warns Greeces Rontis Hellas about Quality System and Medical Device Reporting violations in its production of a balloon cathet...

FDA Approves BMS Opdivo Qvantig Injection

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FDA approves Bristol Myers Squibbs Opdivo Qvantig subcutaneous injection for several cancer indications.

FDA Approves Novo Hemophilia Prophylaxis Drug

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FDA approves Novo Nordisks Alhemo as a prophylaxis for some hemophilia patients.