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 ...

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

NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (Germany: J90) (" NurExone " or the " Company "), a biopharmaceutical company developing exosome-based regenerative therapies, is pleased to announce ...

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 ...

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 ...

PRP has offered to pay $25 million to $30 million to complete construction of an electrical substation to serve STAMP tenants, rather than have the agency rely on state funding to complete the ...

One of Royal Mail’s Christmas stamps may ring some bells for some people in Northern Ireland. This year’s festive collection features illustrations of five cathedrals, including St Patrick’s ...

In the Autumn Budget, stamp duty for buy-to-let properties and second homes increased by two percentage points. The table shows the current buy-to-let stamp duty rates in England and Northern Ireland.

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 ...