Medivis First to Receive FDA Clearance for Augmented Reality Navigation in Neurosurgery
Medivis; FDA 510(k) clearance; augmented reality; AR navigation; cranial neurosurgery; intraoperative guidance; cranial navigation platform; external ventricular drain; ICU bedside procedures; surgical intelligence; spine navigation; neurosurgery innovation
Sanofi Licenses ADEL’s Tau-Targeting Alzheimer’s Drug for $1.04 Billion Deal Including $80M Upfront
Sanofi; ADEL; Alzheimer’s; tau-targeting; licensing deal; biotech
FDA Advances Real-World Data Use and Early-Phase Trial Reforms to Accelerate Drug Approvals
FDA; real-world data; real-world evidence; RWE; early-phase trials; drug approval; Marty Makary; Trump
The 5 Most Painful Clinical Trial Failures of 2025
clinical trial failures; 2025; biotech; gene therapy; MS; DMD; FDA approvals
J&J’s Tecvayli and Darzalex Combo Wins FDA’s Proactive National Priority Voucher for Relapsed/Refractory Multiple Myeloma
J&J; FDA; National Priority Voucher; Tecvayli; Darzalex; Multiple Myeloma; CNPV; ASH 2025
Kyverna to seek FDA engagement after positive autoimmune CAR-T data in stiff person syndrome
Kyverna; KYV-101; CAR-T; autoimmune disease; stiff person syndrome; SPS; FDA; regulatory path; cell therapy
Sanofi returns to Dren Bio for another B‑cell depletion therapy with $100M upfront
Sanofi; Dren Bio; B-cell depletion; autoimmune diseases; strategic collaboration; bispecific antibody; myeloid cell engager; immunology; $100M upfront; licensing deal
Noom Launches Proactive Health Microdose GLP-1 Program for Lower BMI Group Beyond Obesity Labels
Noom; GLP-1 microdosing; Proactive Health; BMI 21+; longevity; preventive health
FDA Approves Enhertu-Perjeta Combo for First-Line Treatment of HER2+ Metastatic Breast Cancer
Enhertu; Perjeta; FDA approval; HER2-positive; metastatic breast cancer; first-line
China’s fast, low-cost gene and cell therapy testing boom draws Western interest
China clinical trials; gene therapy; cell therapy; advanced therapy medicinal products; ATMP regulation China 2025; shortened clinical trial review; cheap clinical trials; Western biotech in China; NMPA CDE reforms; novel therapies testing