Breaking News, Trials & Filings

FDA Grants Samumed ODD

For SM08502 for the treatment of pancreatic cancer

Samumed, LLC announced that the U.S. Food and Drug Administration granted orphan drug designation (ODD) for SM08502 for the treatment of pancreatic cancer.    A phase 1, open‐label, multicenter, dose escalation study is currently evaluating the safety, tolerability, and pharmacokinetics (PK) of orally administered SM08502 in subjects with advanced solid tumors. “The FDA ODD designation for SM08502 is an important regulatory milestone and highlights the importance of finding treatment...

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