Celsion Receives Fast Track Designation For ThermoDox® Development Program To Treat Primary Liver Cancer
Celsion Receives Fast Track Designation For ThermoDox® Development Program To Treat Primary Liver Cancer
Celsion Corporation (Nasdaq: CLSN ), a leading oncology drug development company, today announced that the U.S. Food and Drug Administration (FDA) has designated the HEAT Study of its investigational drug, ThermoDox®, in combination with radiofrequency ablation (RFA), as a Fast Track Development Program.
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Categories: Breast Cancer Risks Tags: cancer, Celsion, Designation, Development, fast, liver, Primary, program, receives, ThermoDox®, track, treat
FDA Grants Priority Review Designation to Denosumab Biologics License Application for the Reduction of Skeletal …
FDA Grants Priority Review Designation to Denosumab Biologics License Application for the Reduction of Skeletal …
Amgen today announced that the U.S. Food and Drug Administration has granted priority review designation to denosumab, a subcutaneous RANK Ligand inhibitor, for the treatment of bone metastases to reduce skeletal related events in patients with cancer.
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Categories: Breast Cancer Risks Tags: application, Biologics, Denosumab, Designation, Grants, License, priority, reduction, Review, Skeletal
FDA grants orphan drug designation to pralatrexate for treatment of advanced TCC of urinary bladder
FDA grants orphan drug designation to pralatrexate for treatment of advanced TCC of urinary bladder
Allos Therapeutics, Inc. announced today that the U.S. Food and Drug Administration has granted orphan drug designation to pralatrexate for the treatment of advanced or metastatic transitional cell carcinoma of the urinary bladder, a form of bladder cancer. The Company is currently investigating pralatrexate in a Phase 2 clinical study in patients with advanced or metastatic relapsed TCC of the …
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Categories: Breast Cancer Treatment Tags: advanced, Bladder, Designation, drug, Grants, Orphan, pralatrexate, Treatment, urinary
Keryx Biopharmaceuticals’ perifosine receives FDA Fast Track Designation
Keryx Biopharmaceuticals’ perifosine receives FDA Fast Track Designation
Keryx Biopharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for KRX-0401 (perifosine), the Company’s novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, for the treatment of refractory advanced colorectal cancer.
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Categories: Breast Cancer Research Tags: Biopharmaceuticals', Designation, fast, Keryx, perifosine, receives, track
BioSante Announces FDA Orphan Drug Designation for GVAX Pancreatic Cancer Vaccine
BioSante Announces FDA Orphan Drug Designation for GVAX Pancreatic Cancer Vaccine
LINCOLNSHIRE, Ill.—-BioSante Pharmaceuticals, Inc. today announced BioSante’s receipt of Orphan Drug designation from the FDA’s Office of Orphan Products Development for GVAX Pancreas Vaccine in the treatment of pancreatic cancer.
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Categories: Breast Cancer Risks Tags: Announces, BioSante, cancer, Designation, drug, GVAX, Orphan, pancreatic, vaccine