CHMP Recommends Ocrevus Approval for Pediatric Relapsing MS
CHMP recommends Ocrevus pediatric relapsing MS approval for children aged 10+, advancing toward European Commission authorization within two months.
FDA approves imlunestrant plus abemaciclib for ESR1-mutated breast cancer
FDA approves imlunestrant plus abemaciclib for ESR1-mutated breast cancer, doubling progression-free survival in Phase 3 trials.
Certara Launches External Data Accelerator for CDISC Standards Compliance
Certara launches External Data Accelerator to catch vendor data conformance issues before submission, addressing 70% of clinical study data...
Boehringer Ingelheim launches PED Essentials for patient data collection
Boehringer Ingelheim's PED Essentials teaches patient organizations to collect and structure patient experience data for regulatory submissions and advocacy.
SkinCure Analysis: Nonmelanoma Skin Cancer Cases 42% Higher Than Official Count
New analysis suggests nonmelanoma skin cancer cases are 42% higher than official counts, with annual patient numbers reaching 4.7...
CDC Reports 17% Surge in Rabies Inquiries; Kamada Confirms KedRAB Supply
Kamada confirms KedRAB supply meets surge in rabies inquiries. CDC reports 17% increase in rabies-related cases through summer 2026.
MIRA Pharmaceuticals Initiates Phase 2a Study of Ketamir-2 for Chemotherapy-Induced Peripheral Neuropathy
MIRA Pharmaceuticals initiates Phase 2a study of Ketamir-2 for chemotherapy-induced peripheral neuropathy, targeting an undertreated condition affecting over ha
PEDMARK Hearing Protection Shows No Cancer Efficacy Compromise in Study
PEDMARK hearing protection met its primary endpoint in a Phase 2 study, showing significant ototoxicity reduction without compromising cisplatin's...
Medpace Expands Phase I Unit With On-Site Imaging and Specialized Assessments
Medpace expands Phase I Unit with on-site imaging and specialized assessments to reduce participant dropout and keep trial endpoints...
RBQM vs. RBDM: Data Teams Must Link Quality Plans to Management Protocols
Risk-based quality management requires linking quality plans to data management protocols. EU regulators now expect documented traceability between RBQM...