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FDA OKs Arrays Braftovi for Some Cancers

[ Price : $8.95]

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FDA issues a draft guidance entitled Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Under...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

[ Price : $8.95]

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

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.

New Sleep Apnea Indication for Lillys Zepbound

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FDA approves a new indication for Lillys Zepbound to treat some obese patients with obstructive sleep apnea.

Astellas Recalls Lots of Prograf and Astagraf

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FDA says Astellas has recalled one lot each of its Prograf and Astagraf transplant medications that may contain empty capsules.

FDA Approves Checkpoints Unloxcyt

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FDA approves Checkpoint Therapeutics Unloxcyt to treat some squamous cell cancer patients.