FDA allows trial expansion for Sunrise's LTK system:
This article was originally published in Clinica
Sunrise Technologies has received conditional approval from the US FDA to replace its Sun 1000 holmium laser system with its new Hyperion laser thermal keratoplasty system at all of its clinical investigation sites in the US. The approval will allow the new device to be tested in a current trial as a treatment for hyperopia ranging from +1.25 to +5.625 dioptres. The system was recommended for approval by an FDA advisory panel earlier this year for the temporary reduction of low to moderate hyperopia in the range of +0.75 to +2.50 dioptres (see Clinica 892, p 21).
You may also be interested in...
Immuno-oncology has produced some exciting successes, but the field has become intensely crowded. Enormous resources are being poured into duplicative work and shaky hypotheses—overshadowing other pursuits in cancer research while producing limited results. It is time to re-evaluate how the sector should be pursuing innovation in cancer and how it can be smarter in its use of resources—financial investment, talent, bandwidth, patients and data.
The Pink Sheet’s list of EU centralized approvals of new active substances has been updated with seven new products including Roche's Polivy for treating diffuse large B-cell lymphoma. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).