Approval could bring GlaxoSmithKline a tropical disease priority review voucher.
The US FDA is bringing GlaxoSmithKline PLC’s single-dose malaria drug Krintafel (tafenoquine) to a July 12 advisory committee meeting despite apparently having no major concerns about the adequacy of the efficacy and safety data to support approval.
In separate voting questions, the agency asks its Antimicrobial Drugs Advisory Committee whether GSK has provided substantial evidence of effectiveness for tafenoquine for the radical cure of Plasmodium vivax malaria in patients 16 years of age and
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Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
