The European Medicines Agency’s (EMA’) human medicines committee (CHMP) has recommended two new medicines and three ...

The tool reduces pathologist variability in liver biopsy assessment during trials of treatments for metabolic ...

"We are very pleased with the productive dialogue with the EMA Pediatric Committee and the positive PIP opinion. This approval marks a major regulatory milestone towards the submission of our ...

Novartis (NVS) announced that the Committee for Medicinal Products for Human Use, CHMP, of the European Medicines Agency, EMA, has adopted a positive opinion and recommended granting a marketing a ...

Bristol Myers Squibb Receives Positive CHMP Opinion for the Subcutaneous Formulation of Opdivo® (nivolumab) Across Multiple Solid Tumor Indications ...

Krystal Biotech's VYJUVEK, a first-mover gene therapy for DEB, has received a positive CHMP recommendation. Read why KRYS ...

Lilly in a statement Friday said it will ask the CHMP to reexamine its opinion. Given the drug's approval by regulators in other countries, "Lilly remains confident in the safety and effectiveness of ...