EMA adopted a positive opinion and the European Commission granted marketing authorization for the drug Hopledo.

The entities involved

• European Medicines Agency →

  highest regulatory authority on medicines in the European Union

  • IGC Pharma, Inc. is preparing data for potential U.S. FDA review and seeking EMA support for its lead drug candidate.Mon 14:18
  • Both the FDA and the European Medicines Agency are evaluating NervGen's lead therapeutic candidate.Fri 23:04
• European Commission →

  executive branch of the European Union

  • The European Commission aims to strengthen homegrown AI capabilities while global advanced models face usage restrictions.Mon 17:49
  • The European Commission has initiated economic support measures for Armenia, including funding transfers, trade program development, and import restrictions.Mon 17:26
• Zambon →

  company in Barcelona, Spain

  Nothing else this week.

Related events

• Oncopeptides AB's drug received a positive opinion from the EMA, leading to the European Commission making a final decision for the EU market.Sep 17
• EMA validated marketing authorization and FDA accepted NDA for Pharvaris N.V.'s lead drug.Aug 25
• The European Medicines Agency provided a positive opinion on a drug developed by Novartis.Sep 21