Buoyed by Positive Trial Data, Private Yaupon Prepares To File Topical Chemo For Early CTCL
This article was originally published in The Pink Sheet Daily
FDA orphan R&D grant and academic ties start to pay off for biotech's lead drug, a topical gel of a generic chemotherapy aimed at 20,000 patients with early-stage skin cancer.
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Now called Ceptaris, the company is awaiting FDA approval of mechlorethamine gel, a topical formulation of a cytotoxin, for early-stage CTCL.
With FDA's approval a week ahead of the PDUFA date, Gloucester Pharmaceuticals will bring its first product to market, the second HDAC inhibitor approved in cancer.
FDA To Follow EMEA's Lead: ODAC Votes To Require Randomized Controlled Trials For Future Cutaneous T-Cell Lymphoma Drug Approval
FDA may soon follow the European Medicine Agency's lead in approval standards for cutaneous T-cell lymphoma drugs by requiring randomized clinical trials for future drug development