PDS0101 Plus Pembrolizumab Shows 39.3-Month Survival in HPV16 Head and Neck Cancer
PDS0101 Plus Pembrolizumab achieved 39.3-month median overall survival in HPV16-positive head and neck cancer, published in JAMA Oncology.
IMVT-1402 Misses Primary Endpoint in Cutaneous Lupus Proof-of-Concept Trial
IMVT-1402 missed its primary endpoint in a cutaneous lupus proof-of-concept trial, failing to show statistically significant improvement on CLASI-A...
Astellas Starts Phase 3 Trial of Setidegrasib vs Docetaxel in KRAS G12D Lung Cancer
Astellas launches Phase 3 trial comparing setidegrasib vs docetaxel in KRAS G12D lung cancer patients, targeting a previously untreated...
FDA Advisory Panel Votes 7-2 to Support Galleri Multi-Cancer Blood Test
FDA advisory panel votes 7-2 to support Galleri multi-cancer blood test, with the agency's final decision expected within months.
FDA Approves Lyrfigtu for FGFR2-Rearranged Cholangiocarcinoma
FDA approves Lyrfigtu for previously treated FGFR2-rearranged cholangiocarcinoma, offering a second-line option alongside established competitor pemigatinib.
Tekton Research Launches Dedicated Psychiatry Team Across 17 Sites
Tekton Research launches dedicated psychiatry team across 17 sites to address rater drift, diagnostic variability, and participant dropout in...
Vistagen’s fasedienol shows positive data in open-label extension for social anxiety disorder
Vistagen's fasedienol shows positive results in open-label extension for social anxiety disorder, following two Phase 3 primary endpoint misses.
CBL-514 Meets Primary Endpoint in Phase 2 Dercum’s Disease Trial
CBL-514 meets primary endpoint in Phase 2 Dercum's Disease trial, with 90% of patients achieving meaningful pain relief at...
Barzolvolimab Meets All Primary and Key Secondary Endpoints in Phase 3 CSU Trials
Barzolvolimab meets all primary and key secondary endpoints in Phase 3 CSU trials, advancing Celldex's mast cell-targeting treatment for...
Roche’s Sefaxersen Meets Primary Endpoint in Phase 3 IgAN Study
Roche's sefaxersen Phase 3 IgAN study met its primary endpoint, significantly reducing proteinuria versus placebo at 37 weeks in...