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FDA policy sets new clinical trial requirements for drug approvals
The default standard would see US drug and biologic approvals requiring a single, robust pivotal study plus confirmatory evidence, instead of two trials.
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Regulation & Legislation
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GSK wins dual EU approval for its ultra-long-acting biologic Exdensur
The European Commission’s decision covers the treatment’s use in severe asthma and chronic rhinosinusitis.
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AstraZeneca’s Imfinzi plus chemotherapy earns CHMP nod in gastric cancer
If approved, the regimen would become the first immunotherapy-based perioperative therapy for adults with early gastric and gastroesophageal cancers in Europe.
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Pharma benefits in EU-India Free Trade Agreement
Conclusion of ‘landmark’ deal significantly enhances trade, investment and supply chains, notably granting beneficial tariff reductions for the pharma industry.
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EMA and FDA issue joint AI guidance for medicine development
The regulators’ 10 principles aim to support pharma companies with evidence generation and monitoring for new medicines.
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Sentynl secures US-first approval for rare Menkes disease
The US biopharma company can now offer a new treatment option for eligible paediatric patients with the genetic disease.
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Chemical assessment in Europe to be streamlined under new legislation
The European Commission’s new framework aims to improve safety assessment of chemicals to better protect human health and the environment.
webinar
Harnessing AI for more efficient clinical trials
5 January 2026 | By European Pharmaceutical Review
During this virtual panel, industry experts will discuss practical examples and considerations for applying AI in pharma’s clinical trials.
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Europe makes progress in its bid to tackle medicine shortages
And as the Critical Medicines Act advances, so too does the Biotech Act, with the moves attracting mixed support from the region’s pharma industry.
webinar
Practical considerations for aseptic gowning in contamination control strategies
17 December 2025 | By Particle Measuring Systems
Join this webinar as we examine the main personnel-related factors that could lead to particle/microbial contamination risks of the product and outline practical measures that can mitigate these risks.
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CHMP recommends cancer medicines by SFL Pharmaceuticals and Serum Life Science Europe
The EMA’s human medicines committee also recommended approval of drugs by GSK, Moderna, STADA, Lupin Europe and Cytokinetics.
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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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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.
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.
news
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.
