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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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Regs & Legs
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FDA appoints another new CDER director, selecting Dr Tracy Beth Høeg
She will become the fifth leader at the Center, following the surprise retirement decision by her soon-to-be predecessor Richard Pazdur.
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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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CDER director Richard Pazdur to retire from FDA
In the interim, Dr Tracy Beth Høeg will serve as acting director for FDA's Center for Drug Evaluation and Research.
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UK first country to secure zero-tariff US pharmaceuticals deal
New trade deal to “ignite economic growth” and help boost the UK’s position as a superpower in life sciences.
webinar
Realising autonomous pharmaceutical operations
2 December 2025 | By Emerson
Join this webinar to discover how the pharmaceutical industry can move towards sustainable autonomous operations by implementing solutions that enhance pipeline acceleration, flexible manufacturing, operational integrity and real-time release.
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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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BSI launches a world-first environmental standard for the pharma industry
New BSI standard PAS 2090 could reshape how the pharmaceutical industry reports and minimises its environmental footprint.
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European Commission calls for bio-based innovation in new EU Bioeconomy Strategy
Changes proposed in the EU body’s regulatory framework aim to create a competitive and sustainable European bioeconomy.
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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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First biosimilar version of J&J’s Simponi approved in Europe
Authorisation of the biosimilar Gobivaz provides a substitute biologic medicine to Simponi for individuals with immune-mediated diseases.
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Insmed wins first EU approval for non-cystic fibrosis bronchiectasis treatment
Oral small molecule treatment Brinsupri (brensocatib) could become a new standard of care for patients with the progressive lung disease.
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Italian non-profit set for European gene therapy first in Wiskott-Aldrich syndrome
Fondazione Telethon’s Waskyra (etuvetidigene autotemcel) has been recommended for approval by the CHMP as a treatment for the rare disease.
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FDA hits Sarepta with liver warning labelling for its DMD drug Elevidys
As well as the new safety warnings for the Duchenne muscular dystrophy gene therapy, the biopharma company also faced a new, more restrictive licence for the treatment.
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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.
