High-Stakes Meetings With EMA Scheduled For Four EU New Drug Filings
Executive Summary
The sponsors of four medicines that are nearing the end of the regulatory review cycle in the EU could this week be asked to explain why the European Medicines Agency should recommend approving their products.
You may also be interested in...
EMA Backs Approval For Eight New Drugs But Rejects Lagevrio For COVID-19
Janssen’s Akeega is among the latest drugs that the European Medicines Agency says should be approved for use in the EU. Meanwhile, MSD/Ridgeback Biotherapeutics plan to appeal the agency’s rejection of their COVID-19 treatment.
EU Decision Time For Zejula/Zytiga Combo Therapy, Vadadustat & Other Drugs
The European Medicines Agency’s human medicines committee, the CHMP, is this week deciding whether to back the approval of a number of new drugs.
EMA Probe Finds No Link Between GLP-1s And Suicidal Thoughts & Actions
After reviewing the evidence from non-clinical studies, clinical trials, post-marketing surveillance data and other studies, the European Medicines Agency said there was no need to update the product information for 11 diabetes and weight management drugs.