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NewsBristol-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
Eledon Pharmaceuticals Gains FDA End-of-Phase 2 Alignment for Tegoprubart Ahead of Global Phase 3 Kidney Trial
AstraZeneca Plans Regulatory Submission for Anselamimab After CARES Subgroup Data Show Survival Gains
Emergent BioDefense Gains FDA Approval Letter Update for BioThrax Post-Exposure Prophylaxis Labeling
Latest news
11 storiesProQR 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.
Zealand Pharma Advances Petrelintide into Phase 3 as Amylin Analog Obesity Pipeline Expands
Zealand Pharma moves petrelintide into Phase 3, raising immediate manufacturing and formulation demands for CDMOs in obesity therapeutics.
Allogene Achieves Positive Futility Analysis for Cema-Cel in First-Line LBCL Consolidation Trial
Allogene's ALPHA3 futility analysis clears Cema-Cel to continue, raising near-term GMP supply and process validation questions for allogeneic CAR-T.
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Atara Biotherapeutics Secures FDA Type A Meeting Guidance for Tabelecleucel BLA Resubmission
FDA Type A meeting confirms tabelecleucel BLA resubmission path via updated ALLELE trial data, with Pierre Fabre Pharmaceuticals leading the submission.
NurExone Signs Exclusive U.S. GMP Manufacturing MOU with Made Scientific for Exosome Supply
NurExone signs binding MOU with Made Scientific for exclusive U.S. GMP exosome manufacturing, targeting first GMP batches in H1 2027.
Kura Oncology Achieves $9.1M in Ziftomenib Revenue After Two Full Launch Quarters
Kura Oncology's ziftomenib posted $9.1M in Q2 net revenue, up 57%, capturing majority new patient share in R/R NPM1-m AML after two launch quarters.
Worth your time this week
Atea Pharmaceuticals Achieves Phase 3 Success for BEM/RZR Ahead of NDA Filing
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Zealand Pharma Secures USD 100 Million Royalty Sale with Royalty Pharma for Rusfertide Economics
Reviva Pharmaceuticals Awaits FDA Feedback on Brilaroxazine Formulation Change Ahead of Phase 3 RECOVER-2 Enrollment
