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Europe edges closer to formalising new ‘Pharma package’ industry rules
Progress made in the region’s approach to critical medicines and antibiotics as the EU Council and EU Parliament agree a new deal.
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Regs & Legs
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Gamida Cell wins cell therapy first in severe aplastic anaemia from FDA
The US approval for the Ayrmid company’s novel transplant option Omisirge adds to its existing licence in haematological malignancy.
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European Pharmacopoeia updates monoclonal antibody standards
The Ph. Eur. Commission also adopted seven new monographs and two new general chapters at its recent 183rd session.
webinar
Increasing the effectiveness of pharma endotoxin testing
8 December 2025 | By European Pharmaceutical Review, in association with Veolia
During this virtual panel, industry experts will discuss the evolution of endotoxin testing, future trends and key risk mitigation considerations for pharma companies.
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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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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
Is operational complexity limiting your performance? Discover how autonomous technologies are reducing risk and improving quality in pharma organisations.
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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.
