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
Hikma announces CEO change and Board appointment
Hikma Pharmaceuticals; CEO change; Riad Mishlawi; Said Darwazah; Khalid Nabilsi; Board appointment; executive leadership; pharmaceuticals; London; 15 December 2025
Ankyra Therapeutics Appoints Sailaja Battula, PhD as Chief Scientific Officer
Ankyra Therapeutics; Sailaja Battula; CSO appointment; immuno-oncology; biotechnology
NeOnc Technologies Reports Updated Clinical Results for Intranasal NEO100
NeOnc Technologies; NTHI; NEO100; intranasal NEO100; updated clinical results; recurrent astrocytoma; WHO Grade III/IV; radiographic remission; overall survival; compassionate use; Phase 1/2a trial; CNS cancers
Immunome’s desmoid tumor drug varegacestat posts landmark Phase 3 results, setting up a potential challenge to Merck KGaA’s Ogsiveo
Immunome; varegacestat; desmoid tumors; Phase 3 RINGSIDE trial; gamma secretase inhibitor; Merck KGaA; Ogsiveo; progression-free survival; objective response rate; rare tumors; oncology; NDA filing
Aviceda’s AVD-104 misses Phase 2b primary endpoint vs Izervay but still headed to Phase 3
Aviceda; AVD-104; geographic atrophy; dry AMD; Phase 2b; SIGLEC trial; Izervay; avacincaptad pegol; clinical trial failure; Phase 3 prospects