Pfizer/Ligand’s Osteoporosis Drug Fablyn Gets Advisory Committee Review
This article was originally published in The Pink Sheet Daily
Lasofoxifene beats out Wyeth’s Viviant for first advisory committee review of the competing next-generation SERMs.
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Analysis sought for treatment indication is similar to what FDA requested for prevention setting.
Selective estrogen receptor modulator now is called Fablyn rather than Oporia, a name under which it received two “not approvable” letters.
Firm continues to plan an additional submission this year for an osteoporosis treatment claim.