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FDA Questions Value of Semuloparin Injection for Cancer Patients
"These findings call into question the clinical value of semuloparin in the proposed clinical setting," the FDA reviewers said in documents posted online on Monday.
The FDA staff review comes ahead of an advisory panel, which will vote on whether to recommend semuloparin on Wednesday. The FDA usually follows panel recommendations, although it is not required to, and will make a final decision later.Read the Reuters article here.