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CDER Approved 50 Novel Products Last Year

[ Price : $8.95]

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

Ionis Spinraza Approved by FDA for SMA

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

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 Galderma Dermatitis Drug Nemluvio

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

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FDA issues a draft guidance entitled Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Under...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

Guide on Drug Batch Uniformity and Integrity

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FDA posts a draft guidance entitled Considerations for Complying With 21 CFR 211.110 that describes how to comply with batch unifo...

Chimerix NDA for Glioma Drug

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Chimerix files an NDA seeking accelerated approval for dordaviprone as a treatment for patients with recurrent H3 K27M-mutant diff...