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September 16, 2016
The new treatment for soft tissue sarcoma has been recommended for conditional marketing authorization in the EU.
The agency has recommended marketing authorization for Ibrance in the European Union.
September 02, 2016
Swab recovery parameters are reviewed in detail to define best practices and highlight common mistakes to assure successful recovery studies using a risk-based approach.
August 15, 2016
The agency has adopted guidelines on the pharmacovigilance of biological drugs.
August 11, 2016
The agency released the GMP guidance to help manufacturers ensure accurate data and minimize risk.
August 09, 2016
The three-year report emphasizes the roll of collaboration in drug safety.
August 04, 2016
The report addressed how the agency might support medicine development for patients’ unmet medical needs.
The agency launched a public consultation on the revised guidance for new medicines to treat tuberculosis.
August 01, 2016
The pharmaceutical industry now braces itself for the consequences and complexities that could follow in the wake of the United Kingdom’s decision to leave the European Union.
July 22, 2016
The agency will review Mylan and Biocon’s biosimilar to pegfilgrastim.