The New Rules Of AI In Pharma: What FDA And EMA's 10 Guiding Principles Mean For Your Business

For pharmaceutical and life sciences companies ready to embrace this moment, the 10 principles aren't a burden. They're a ...

Ray Therapeutics receives EMA PRIME status for gene therapy

Ray Therapeutics has received priority medicines (PRIME) designation from the European Medicines Agency (EMA) for its RTx-015 ...
Medscape

EMA Pushes Earlier Intervention in Rare Pediatric Diseases

The EMA has backed broader pediatric use of Agamree and Crysvita, lowering age thresholds for rare genetic diseases affecting muscle and bone development.
Medscape

EMA Broadens Use of Targeted Combinations in Blood Cancers

The EMA has recommended label expansions for Inaqovi, Opdivo, and Venclyxto, broadening treatment options in AML, Hodgkin lymphoma, and CLL.
RAPS

EMA details data quality considerations when using RWD

The European Medicines Agency (EMA) has finalized a document with recommendations on using the European Medicines Regulatory Network (EMRN) Data Quality Framework (DQF) when submitting premarket ...