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Bristol Myers Squibb wins fifth US approval for CAR T cell therapy Breyanzi
The FDA’s latest authorisation makes it the most widely approved of any CD19-directed CAR T therapy in cancer.
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Clinical Trials
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J&J biologic Imaavy achieves EU first in generalised myasthenia gravis
The monoclonal antibody becomes the first neonatal Fc receptor (FcRn) blocker to be approved in Europe for the condition.
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Regeneron and Tessera partner to develop gene therapy for AATD
The in vivo, one-time gene editing therapy has potential to transform outcomes for alpha-1 antitrypsin deficiency (AATD).
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European Pharmaceutical Review Issue 4 2025
EPR Issue 4 includes articles on manufacturing, AI/ML, vaccine development, biologics and more.
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AbbVie’s atogepant illustrates migraine therapy label expansion potential
If approved in Europe, atogepant would provide patients with a new acute treatment option for migraine attacks.
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Dupixent receives first-in-decade EU approval in chronic spontaneous urticaria
European approval of Sanofi and Regeneron’s monoclonal antibody provides eligible urticaria patients with a new first-line targeted treatment option.
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MHRA approves Leqembi IV maintenance as additional Alzheimer’s option
Decision provides UK Alzheimer’s patients with an alternative administration method for Eisai and Biogen’s antibody drug.
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Genetically engineered iPSCs see clinical-scale platelet manufacturing potential
By utilising patient-derived instead of donor-derived platelets, the method could offer a safer approach to platelet transfusions.
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Roche’s fenebrutinib shows best-in-disease potential in multiple sclerosis
Phase III data suggest the drug could be the first high-efficacy, oral therapy for relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis.
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MHRA set to overhaul the UK’s rare disease drug regulatory pathway
The medicines regulator will aim to take a more flexible licensing approach for the research and manufacture of rare disease therapies in the UK.
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FDA draft guidance on biosimilars offers “regulatory relief”
US agency follows in footsteps of European Medicines Agency (EMA) in efforts to streamline biosimilar development.
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Sirolimus-eluting balloon offers potential “paradigm shift” in restenosis treatment
Treatment provided a promising alternative to standard care in repeat percutaneous coronary interventions in the first-of-a-kind trial.
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Alexion wins EU label expansion for kinase inhibitor Koselugo
Approval provides continuity of care into adulthood for patients with neurofibromatosis type 1 (NF1) using Koselugo (selumetinib) to manage symptoms.
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Novartis strengthens neuroscience pipeline with $12bn Avidity acquisition
Deal to advance potential first-in-class RNA therapeutics focused on genetic neuromuscular diseases such as Duchenne muscular dystrophy.
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Lilly’s baricitinib exhibits paediatric potential in major alopecia areata study
Results from the phase III study signify a successful collaboration with biopharma firm Incyte.
