specifically in comparing approval regulatory cycles for the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Last year we wrote a three-part series, "Life in the Fast ...

It's not known whether the company will submit a separate application for approval to the UK regulator, the MHRA. The European Medicines Agency based its decision on two main studies of more than ...

The CHMP recommended approval granting marketing authorization ... with generally low-grade symptomatic adverse events. The European Commission (EC) will decide in approximately two months.

About AVT23 AVT23 is a monoclonal antibody and proposed biosimilar to Xolair ® (omalizumab). AVT23 is an investigational compound and has not received regulatory approval in any country. Biosimilarity ...

The European Medicines Agency has recommend olaparib for approval for women with ovarian cancer who have a BRCA mutation - the first time a cancer drug will have been approved targeted at an inherited ...

As members of the ECNP, Child and Adolescent Network, we were privileged to work not only with colleagues from the European Medicines Agency (EMA ... Adapting the approval process so that ...

The Institute of Cancer Research, London, has welcomed the approval of olaparib by the European Medicines Agency for women with ovarian cancer who have a BRCA1 or BRCA2 mutation. Olaparib, a PARP ...

The US-developed NOVAVAX vaccine against COVID-19 has been approved Monday by the European Medicines Agency (EMA), thus becoming the fifth drug of its kind to become available at a continental level.

Biocon Biologics, a subsidiary of Biocon, on Monday got approval from the European Medicines Agency (EMA) to manufacture biosimilar Bevacizumab in India. The company, in a statement, said that the ...

Bayer has submitted an EMA application for darolutamide combined with ADT for metastatic hormone-sensitive prostate cancer. The Phase 3 ARANOTE trial showed darolutamide with ADT reduced ...

announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Kisqali (ribociclib). The CHMP recommended approval ...