• FDA Panel Unhappy With Novel OA Pain Drug

    7 monthes ago - By MedPageToday

    An FDA advisory panel voted overwhelmingly - 19-1 - that a proposed Risk Evaluation and Mitigation Strategy program would not ensure a favorable benefit-risk balance for tanezumab, a nerve growth factor inhibitor...
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  • FDA panel rejects Pfizer's tanezumab for osteoarthritis pain over risk-benefit doubts

    FDA panel rejects Pfizer's tanezumab for osteoarthritis pain over risk-benefit doubts

    7 monthes ago - By Healio

    A pair of FDA advisory committees has rejected a risk mitigation proposal from Pfizer for its NGF-blocker tanezumab, stating it would fail to ensure the drug's benefits outweigh its risks for patients with osteoarthritis.
    In a 19-1 vote, members of the FDA's Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee ruled that while clinical data suggest tanezumab can benefit patients with OA, the associated risk for joint destruction, or rapidly progressing osteoarthritis , and other safety outcomes was
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  • FDA panel rejects Pfizer's arthritis drug as too risky

    7 monthes ago - By ABC News

    A panel of U.S. health advisers says an experimental arthritis drug is too risky, even with limits on its use
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