news
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.
List view / Grid view
Regs & Legs
news
Europe marks key milestone in adopting Critical Medicines Act
EU Parliament agrees clear priorities for future negotiations on the act, including investing in pharma manufacturing capacity.
news
EU concludes major free trade agreement with Mercosur countries
European pharma industry acknowledges the progress made, particularly with partial tariff reductions, but said further provisions could have been achieved.
news
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.
news
European Pharmacopoeia publishes new data quality framework
New general chapter on quality of data 5.38 supports stakeholders with digitalisation during pharmaceutical quality decision-making.
news
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.
news
Sanofi wins EU approval for its type 1 diabetes biologic Teizeild
The European Commission’s decision will make the product the first disease-modifying treatment to be available for the condition in Europe.
news
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.
news
Endotoxin testing milestone reached with European Pharmacopoeia’s animal shift
The quality control (QC) standards publication sets animal-free bacterial endotoxins testing (BET) as the new norm in Europe.
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.
news
J&J’s Rybrevant-Lazcluze combination wins FDA first in lung cancer
US approval of the subcutaneous therapy provides a novel chemotherapy-free frontline option in EGFR-mutated NSCLC.
news
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.
news
AstraZeneca and Daiichi’s Enhertu wins first-in-decade US oncology approval
FDA approval of the drug in combination with Perjeta initiates a $150 million milestone payment to Daiichi Sankyo from AstraZeneca under their joint collaboration.
news
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.
