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EMA

EMA Adopts Positive Opinion for Bekemv (biosimilar, eculizumab) to Treat Paroxysmal Nocturnal Haemoglobinuria

EMA Adopts Positive Opinion for Bekemv (biosimilar, eculizumab) to Treat Paroxysmal Nocturnal Haemoglobinuria

  • February 23, 2023
The EMA and HMA Acquired Big Data Strategy to Folster Veterinary Therapies in the EU

The EMA and HMA Acquired Big Data Strategy to Folster Veterinary Therapies in the EU

  • June 15, 2022
The EMA Rejects Prestige BioPharma’s Tuznue and Hervelous, a proposed biosimilars of trastuzumab for HER2-Positive Breast and Gastric Cancers

The EMA Rejects Prestige BioPharma’s Tuznue and Hervelous, a proposed biosimilars of trastuzumab for HER2-Positive Breast and Gast...

  • May 20, 2022
Incyte Reports EMA's Validation of MAA for Ruxolitinib Cream to Treat Vitiligo

Incyte Reports EMA's Validation of MAA for Ruxolitinib Cream to Treat Vitiligo

  • October 29, 2021
Novartis Reports the US FDA and EMA's Acceptance of sBLA for Kymriah (tisagenlecleucel) and Granted Priority Review to Treat R/R Follicular Lymphoma

Novartis Reports the US FDA and EMA's Acceptance of sBLA for Kymriah (tisagenlecleucel) and Granted Priority Review to Treat R/R F...

  • October 29, 2021
ADC Reports EMA's Validation of MAA for Zynlonta to Treat R/R Diffuse Large B-Cell Lymphoma

ADC Reports EMA's Validation of MAA for Zynlonta to Treat R/R Diffuse Large B-Cell Lymphoma

  • October 29, 2021
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