FDA grants accelerated approval to Voceryq for recurrent respiratory papillomatosis; FDA eases travel limit in speech implant study

• FDA Oct 30, 2026
  FDA grants accelerated approval to Voceryq, a plasmid DNA immunotherapy, for adults with recurrent respiratory papillomatosis
  The Food and Drug Administration (FDA) granted accelerated approval to Inovio Pharmaceuticals' Voceryq for adults with recurrent respiratory papillomatosis, in which wart-like growths caused by HPV types 6 and/or 11 form in the airways and can cause hoarseness and voice changes. In an open-label trial of 32 adults who had two or more surgeries to remove laryngotracheal papillomas in the prior 12 months, seven of 26 patients (27%) with at least three baseline surgeries needed no surgery in the first year after treatment. The manufacturer must run post-approval trials to verify clinical benefit, the FDA said.
  Source: FDA
• FDA Oct 26, 2026
  FDA approves Paradromics protocol change dropping four-hour travel limit in speech brain-computer interface study
  Paradromics said the Food and Drug Administration (FDA) approved an amendment to the protocol of its Connect-One early feasibility study of the implanted Connexus brain-computer interface, removing the requirement that participants live within a four-hour drive of a study site, according to a company release. The device translates intended speech into digital communication, and the study is evaluating its long-term safety and performance in people with severe motor impairment, the company said. Sites include UC Davis Health, Mass General Brigham and University of Michigan Health.
  Source: Paradromics via BioSpace

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