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Ionis Spinraza Approved by FDA for SMA

[ Price : $8.95]

FDA approves Ionis Spinraza as the first drug approved to treat children and adults with spinal muscular atrophy.

Guide on Device Supply Interruption Notifications

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FDA posts a final guidance entitled Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under...

Guide on Seeing if Confirmatory Study Underway

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FDA issues a draft guidance entitled Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Under...

Inogen Airway Clearance Device Cleared

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FDA clears an Inogen 510(k) for the Simeox 200 Airway Clearance Device.

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.

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FDA posts a draft guidance entitled Considerations for Including Tissue Biopsies in Clinical Trials.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FDA releases a draft guidance entitled Considerations for the Use of Artificial Intelligence (AI) to Support Regulatory Decision-M...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...