Animals Rule: SIGA’s Smallpox Drug Tecovirimat Sails Through US FDA Panel
Antiviral wins unanimous endorsement on strength of efficacy data in two animal models and absence of major safety concerns in humans. FDA's advisors also see potential utility in other orthopoxviruses, particularly naturally occurring monkeypox outbreaks in Africa.
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Keeping Track: Tpoxx Wins Green Light For Smallpox, Submissions Galore, And A Broader Approval For Xtandi
As many as 14 new products are up for US approval in the third quarter, research by Informa Pharma's Biomedtracker shows. Scrip takes a look at the candidates and their chances of reaching the market.
Alliance for Regenerative Medicine initiative seeks to explain gene and cell therapy to the general public. Also, EY's Giovannetti says strategic decisions, not tax reform, should drive deal-making; FDA's Woodcock touts benefits of new drug review office overhaul; and Siga Technologies eyes priority review voucher upon approval of Tpoxx for smallpox.