Xtandi™ (enzalutamide) was approved for metastatic hormone-sensitive prostate cancer after it reduced the risk of radiographic progression or death by 61 percent in a trial.
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The European Commission (EC)
The combination was approved on Phase III trial results which show it doubled progression-free survival and reduced risk of death by 40 percent, compared to standard of care.
The European Commission has granted marketing authorisation to Roche’s Evrysdi™ (risdiplam) as a treatment for spinal muscular atrophy in infants, children and adults.
The approval of Pemazyre® (pemigatinib) was based on Phase II trial results in which the treatment met its primary endpoint, demonstrating a 37 percent overall response rate.
The addition of €500 million to the EU’s existing COVAX Facility pledge was announced at the G7 summit virtual leaders' meeting.
The European Commission approval makes KEYTRUDA® (pembrolizumab) the first anti-PD-1 therapy approved for metastatic microsatellite instability-high (MSI-H) colorectal cancer patients in Europe.
This article explores the reasons behind the introduction of the EU Medical Device (MDR) and In Vitro Diagnostic Devices (IVDR) regulations, the problems that beset them and how COVID-19 finally persuaded the European Commission that a further year’s preparation time for full application of the regulations was necessary.
Earlier this year, Johnson & Johnson announced the first major regulatory approval of a vaccine developed by Janssen for the prevention of Ebola. Nikki Withers spoke with the Global Head of Vaccines, Johan Van Hoof, to discover what technologies were used and how they are now being leveraged to develop…
European Pharmaceutical Review investigates five of the latest cancer drug approvals and clinical trial results.