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Delcath's cancer-treating system lands U.S., Australian regulatory wins

Mon, 11/05/2012 - 3:26pm
Mass Device

Medical device company Delcath Systems lands Australian approval for its cancer-treatment system, and lands a definitive date with the FDA to review the device under a New Drug Application.

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Medical device company Delcath Systems (NSDQ:DCTH) is on a roll, notching a couple new regulatory milestones this month for its organ-isolating ChemoSat chemotherapy treatment systems.

Delcath today announced that its 2nd-generation ChemoSat won regulatory approval from Australia's Therapeutic Goods Administration and that the FDA granted the company a June 13, 2013, date for standard review of its recently accepted New Drug Application.

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