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NurExone Achieves MBP-Positive Cell Signal in ExoPTEN Spinal Cord Preclinical Program
NurExone reports MBP-positive cell increases in ExoPTEN-treated spinal cord tissue, adding mechanistic data to prior functional recovery findings.
Gland Pharma Appoints Deepak Sapra as Chief Executive Officer
Lantheus Gains FDA Approval for TAUKLARIFY Tau PET Imaging Agent in Alzheimer's Disease
Moleculin Biotech Achieves Threefold CR Advantage in MIRACLE Trial Ahead of 2027 NDA Path
Capricor Therapeutics Faces 9-3 AdCom Rejection for Deramiocel in Duchenne Cardiomyopathy
Latest news
11 storiesBristol-Myers Squibb Gains FDA Accelerated Approval for Iberdomide in Relapsed or Refractory Multiple Myeloma
FDA grants accelerated approval to BMS's iberdomide (Zenbexus) for RRMM, triggering mandatory REMS enrollment for specialty pharmacies and distributors.
Eton Pharmaceuticals Gains FDA Fast Track for AMGLIDIA and Targets 2027 NDA with ASN-001 Acquisition
Eton Pharmaceuticals reports 99% revenue growth in Q2 2026 while advancing FDA Fast Track, a PAS filing, and a 2027 NDA target across its rare disease pipeline.
Eledon Pharmaceuticals Gains FDA End-of-Phase 2 Alignment for Tegoprubart Ahead of Global Phase 3 Kidney Trial
Eledon secures FDA End-of-Phase 2 alignment for tegoprubart, setting the regulatory and CMC framework for a 600-patient global Phase 3 kidney transplant trial due late 2026.
AstraZeneca Plans Regulatory Submission for Anselamimab After CARES Subgroup Data Show Survival Gains
AstraZeneca plans to submit CARES subgroup data for anselamimab to regulators, citing 62% survival improvement in AL amyloidosis patients.
Emergent BioDefense Gains FDA Approval Letter Update for BioThrax Post-Exposure Prophylaxis Labeling
FDA's November 2025 approval letter updates BioThrax labeling; biologics QA teams should note PEP co-administration language and document control implications.
ProQR Therapeutics Achieves First Clinical Validation of Axiomer RNA Editing Platform with AX-0810 Data
ProQR's AX-0810 confirms first clinical target engagement for Axiomer RNA editing, triggering a multi-asset regulatory and manufacturing ramp through 2027.
Karyopharm Files Selinexor sNDA in August Under Accelerated Approval for Myelofibrosis Combination
Karyopharm targets August sNDA submission for selinexor plus ruxolitinib in myelofibrosis under Accelerated Approval, with Priority Review requested.
Bioneeds India Appoints Dr. Girish Joshi as Chief Operating Officer
Bioneeds India appoints Dr. Girish Joshi as COO as India's pharma exports hit USD 8.1 billion in Q1 FY27.
Cabaletta Bio Selects ElevateBio as Second CDMO for Rese-cel CAR T Manufacturing
Cabaletta Bio adds ElevateBio as a second CDMO for rese-cel, building manufacturing redundancy ahead of a planned 2H27 BLA submission.
Biomea Fusion Doses First Patient in OPAL Icovamenib-Semaglutide Combination Obesity Study
Biomea Fusion doses first OPAL participant in icovamenib-semaglutide combination study, raising clinical supply and API planning considerations.
Cellectar Biosciences Plans Mid-2027 NDA Submission for Iopofosine I 131 Under FDA Accelerated Approval
Cellectar targets mid-2027 NDA submission for iopofosine I 131 under FDA Accelerated Approval as Phase 3 site activation begins.
Worth your time this week
Zealand Pharma Advances Petrelintide into Phase 3 as Amylin Analog Obesity Pipeline Expands
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Allogene Achieves Positive Futility Analysis for Cema-Cel in First-Line LBCL Consolidation Trial
Atara Biotherapeutics Secures FDA Type A Meeting Guidance for Tabelecleucel BLA Resubmission
