Amgen/UCB To Appeal EMA’s 'Over Cautious' Evenity Rejection
Amgen and UCB say that the European Medicines Agency’s re-examination process should allow them to clarify their position on the data supporting the marketing authorization application for their osteoporosis drug, Evenity. Meanwhile, three other drugs received a positive opinion from the EMA this week for pan-EU approval, including La Jolla’s Giapreza.
You may also be interested in...
Seven new products, including the world’s first ever Ebola vaccine, are on track to receive EU-wide approval. Meanwhile, two drugs have failed to make the grade.
A number of companies were due or potentially due to appear before the European Medicines Agency’s drug evaluation committee, the CHMP, this week to answer questions in person about their marketing applications.
It's decision time again at the European Medicines Agency and Roche's Polivy and AstraZeneca's Qternmet are among the products up for an opinion on whether they should be approved in the EU.