New Filings At The EMA

New medicines under evaluation at the European Medicines Agency.

This is a regularly updated list of products that have been filed with the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) under the EU's centralized authorization procedure.

The information is based on the list of new medicines under review at the EMA that the agency updates every...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Europe

BioMarin Fights Back After NICE Blocks English Funding For £500K Batten Disease Drug

 

The health technology assessment institute, NICE, said the price BioMarin was asking for Brineura was too high, even though its appraisal committee applied a cost-effectiveness threshold ten times higher than usual.

GDPR Clarity For Pharma: Industry Code Nears EU-Wide Approval After Six-Year Journey

 
• By 

The pharmaceutical industry is edging closer to EU-wide clarity on how the bloc’s data privacy rules can be applied consistently to clinical trials and pharmacovigilance activities.

UK Initiative Steps Up Efforts To Tackle Recruitment Bottlenecks In Dementia Trials

 

A government-backed program is working on improving the ability to run dementia clinical trials in the UK, and access to trials for participants.

More from Geography

Inside Elamipretide’s CRL: Clinical And Surrogate Evidence Deficiencies, And A Path Forward

 
• By 

The Pink Sheet takes an exclusive look at the complete response letter, which shows the information on application deficiencies that could become widely available if FDA leaders succeed in releasing CRLs in real time.

Lilly’s Price Deal For Mounjaro In UK A Harbinger Of The MFN Future?

 
• By 

The arrangement, which implies a behind the scenes negotiated discount, may signal a trend toward less price transparency in foreign markets as manufacturers parry Trump’s Most Favored Nation price demands.

GDPR Clarity For Pharma: Industry Code Nears EU-Wide Approval After Six-Year Journey

 
• By 

The pharmaceutical industry is edging closer to EU-wide clarity on how the bloc’s data privacy rules can be applied consistently to clinical trials and pharmacovigilance activities.