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December 5, 2012
18:02 EDTDCTHDelcath Systems announces modification of NDA for liver treatment
Delcath Systems announced that after recent discussions with the FDA, management has elected to modify the label indication it is seeking in its New Drug Application for its proprietary chemosaturation system with melphalan hydrochloride for injection. Although the company's Phase 3 trial demonstrated a very positive signal in patients with liver dominant cutaneous melanoma, based upon a recommendation from the FDA, Delcath has decided to focus the company's NDA indication on the treatment of patients with unresectable metastatic ocular melanoma in the liver. The company believes that its data in ocular melanoma metastases in the liver, coupled with the large unmet need for treatments for this disease, presents the most compelling case for the company's NDA.
News For DCTH From The Last 14 Days
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May 29, 2015
09:04 EDTDCTHDelcath Systems announces results from CHEMOSAT Delivery System
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May 27, 2015
08:05 EDTDCTHDelcath Systems's Chemosat shows positive results in Opinion Leader Forum
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May 26, 2015
09:26 EDTDCTHDelcath Systems names Dr. Jennifer Simpson president and CEO
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May 21, 2015
08:07 EDTDCTHDelcath Systems begins enrollment for Phase trial of Melphalan/IDS
Delcath Systems' intrahepatic cholangiocarcinoma study cohort of its expanded Global Phase 2 Clinical Trial Program of Melphalan/HDS for use in the treatment of patients with unresectable hepatocellular carcinoma - primary liver cancer, or HCC - has opened for patient enrollment. The ICC study will be conducted at the same hospitals in Europe participating in the company's Phase 2 HCC trial, and ICC enrollment is now open at Goethe University Hospital in Frankfurt, the Medical School Hannover and Jena University Hospital. Additional centers in Germany and the U.K. are expected to open for enrollment in the coming weeks.

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