EU Authorizes Pfizer-BioNTech XFG COVID-19 Vaccine for 2026-2027
EU authorizes Pfizer-BioNTech XFG COVID-19 vaccine for 2026-2027 with cross-reactive immunity data across multiple JN.1 lineage variants.
Selinexor Phase 3 Trial Misses Primary Endpoint in Endometrial Cancer
Selinexor Phase 3 Trial missed its primary endpoint in endometrial cancer despite a 5.3-month PFS improvement, with p-value falling...
Abivax Clears Pre-NDA Meeting with FDA for Obefazimod in Ulcerative Colitis
Abivax's obefazimod ulcerative colitis drug achieved 50.8%-51.3% remission rates in Phase 3, clearing FDA pre-NDA meeting for adult patient...
FDA Agrees Single Phase 3 Trial Sufficient for ATH434 MSA Approval Path
FDA accepts single Phase 3 trial for ATH434 in Multiple System Atrophy, with approximately 200 patients and 12-month duration...
EyePoint Completes Enrollment of DURAVYU Phase 3 Trials for Diabetic Macular Edema
EyePoint completes enrollment of DURAVYU Phase 3 trials for diabetic macular edema, testing a six-month dosing schedule against aflibercept.
Karyopharm to Submit Selinexor-Ruxolitinib sNDA for Myelofibrosis in August 2026
Karyopharm plans August 2026 sNDA submission for selinexor-ruxolitinib combination in myelofibrosis, targeting accelerated FDA approval based on spleen response
Your Biometrics Vendor Is Not Built for What Your Next Trial Requires
Acrosian's AI-native CRO launch forces a real question: can legacy biometrics vendors support DCT-era data demands, or is your...
A Maternal GBS Vaccine Just Cleared Phase 1/2. Here’s What the Trial Design Tells Us About the Regulatory Gauntlet Ahead.
Pfizer's 6-valent GBS vaccine cleared Phase 1/2 with strong immunogenicity data in pregnant women. Here's what the trial design...
AbCellera, Vertex Partner on Multispecific T-Cell Engagers for Autoimmune Disease
AbCellera and Vertex partner to develop multispecific T-cell engagers for autoimmune disease, advancing beyond earlier oncology-derived formats.
Capricor’s Deramiocel HOPE-3 Trial Misses Primary Endpoint at p=0.09
Capricor's deramiocel HOPE-3 trial missed its primary endpoint with p=0.09, showing a 1.8 percentage point LVEF improvement in DMD...