Serplulimab, Zynyz (retifanlimab) and danicopan are among the new products that the European Medicines Agency has begun reviewing for potential pan-EU marketing approval.
New EU Filings Include Serplulimab For Lung Cancer & Zynyz For MCC
EU marketing applications for eight new products have begun the regulatory review process at the European Medicines Agency.
More from Product Reviews
• By
With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.
• By
Two US FDA advisory committees will discuss results from epidemiological studies that attempted to quantify the prevalence, incidence and risk factors for misuse, abuse, overdose and death with opioid analgesics.
• By
CEO Len Schleifer said during the company’s first quarter earnings call that most of the complete response letters the company has received related to third-party suppliers, not efficacy or safety.
• By
Plozasiran, Arrowhead Pharmaceuticals' treatment for familial chylomicronemia syndrome, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.