FDA Grants Accelerated Approval to Jazz’s Dordaviprone (Modeyso), the First Treatment for Ultra-Rare Brain Tumor

Dordaviprone; Modeyso; FDA approval; H3 K27M-mutant diffuse midline glioma; ultra-rare brain tumor; Jazz Pharmaceuticals; accelerated approval; pediatric brain cancer; Chimerix acquisition; confirmatory trial

XtalPi and DoveTree Announce Landmark $6 Billion AI-Powered Drug Discovery Collaboration

XtalPi; DoveTree Medicines; AI drug discovery; robotics; pharmaceutical R&D; Gregory Verdine; oncology; immunology; neurology; metabolic diseases; collaboration; upfront payment; milestone payments; royalties

Scientists Protest FDA’s Rejection of Replimune’s Tumor Destroying Therapy

Replimune; RP1; FDA rejection; oncolytic immunotherapy; melanoma; clinical trial; IGYNTE study; scientist protest; drug approval; patient heterogeneity

Replimune Awaits FDA Direction After Complete Response Letter for Advanced Melanoma Therapy

Replimune; FDA; Complete Response Letter; RP1; vusolimogene oderparepvec; nivolumab; advanced melanoma; cancer treatment; IGNYTE trial; accelerated approval

ImmuneOnco and Instil Bio’s PD-L1xVEGF Bispecific Antibody Shows Promising Results in Phase 2 Lung Cancer Trial

ImmuneOnco; Instil Bio; IMM2510/AXN-2510; PD-L1xVEGF bispecific antibody; NSCLC; Phase 2 clinical trial; response rate; safety profile; chemotherapy combination; lung cancer

Clinical Roundup: Cardiff, VYNE and NewAmsterdam Report Key Trial Results in Multiple Disease Areas

Cardiff Oncology; VYNE; NewAmsterdam Pharma; clinical trial updates; onvansertib; metastatic colorectal cancer; Alzheimer’s disease; BROADWAY trial; oncology; statistically significant results