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News Breaks
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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April 23, 2015
10:07 EDTDCTHDelcath Systems management to meet with Roth Capital
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April 22, 2015
07:11 EDTDCTHCardiovascular & Interventional Radiological Society of Europe holds conference
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April 21, 2015
08:06 EDTDCTHDelcath Systems approves amendments to its CTAs filed in U.K. and Germany
Delcath Systems announces approval of amendments to its Clinical Trial Authorizations, or CTAs, filed with the U.K.'s Medicines and Healthcare Products Regulatory Agency and Germany's Federal Institute for Drugs and Medical Devices for the expansion of the Company's global Phase 2 program for the treatment of patients with unresectable hepatocellular carcinoma, to include a cohort of patients with intrahepatic cholangiocarcinoma.

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