Pivotal Moment In EU For Potential New Drugs
Janssen’s Ponesimod Up For Approval Recommendation; Veklury Approval Due For Renewal
Executive Summary
Decisions are due on several EU marketing applications at the March meeting of the European Medicines Agency’s drug evaluation committee, the CHMP. Also, a number of companies might be asked to address outstanding issues the CHMP has about products they want to market that are near the final stages of review.
You may also be interested in...
Companies Brace For ‘Oral Explanations’ On EU Filings
Several companies may appear this week before the European Medicines Agency’s human medicines committee, the CHMP, to answer questions about their initial marketing authorization applications or indication extension requests.
PTC Therapeutics' Gene Therapy Plans Hit By Pandemic
PTC Therapeutics is one of many companies in the life sciences sector whose regulatory targets have been adversely affected by the coronavirus pandemic.
Three Cell And Gene Therapies Reach Critical Review Stage In EU
A number of advanced therapies are likely to be approved in the EU this year.