In Brief: Serono's Serostim
Executive Summary
Serono's Serostim: FDA and company agree to extend March 11 user fee deadline for priority review of the human growth hormone product pending further discussion of the Serostim NDA. Serono submitted the NDA for Serostim for AIDS wasting on Sept. 11. A joint FDA advisory committee narrowly recommended against approval of Serostim on March 1 asking the company to identify responders to the therapy ("The Pink Sheet" March 11, p. 17)...
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