EMA recommendation for 2022-2023 seasonal flu vaccine composition
The European Medicines Agency (EMA) has issued the recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for... Read More
European Medicines Agency recommends marketing authorization approval of Bayer’s Baycox Iron injection for piglets
The Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency has, by consensus, adopted a positive opinion recommending... Read More
EMA grants orphan drug status to Stemline’s SL-401 for AML treatment
The European Medicines Agency (EMA) has granted Orphan Drug designation to Stemline Therapeutics’ SL-401 for the treatment of acute myeloid leukaemia (AML).... Read More
What is meaning of compassionate use in drug regulatory affairs?
Expanded access, sometimes called “compassionate use,” is the use of an investigational drug outside of a clinical trial to treat a patient... Read More