Replimune reported that the IGNYTE clinical trial of RP1 plus nivolumab in anti-PD1 failed melanoma showed a 33.6% response rate, with all responses lasting over six months. The treatment was well-tolerated.
The FDA's advisory committee will review Eli Lilly's Phase 3 study on donanemab for Alzheimer's disease on June 10. This review assesses the drug's benefit-risk profile based on significant efficacy results in cognition and daily function.
Amgen announced Phase 3 trial results for Uplizna for IgG4-related disease, achieving an 87% reduction in flare risk. All key secondary endpoints were met with no new safety signals.
Medtronic is recalling specific StealthStation S8 application versions due to a serious software error affecting surgical navigation displays. Medtronic is providing a free software update to fix the problem.