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 ...
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 ...
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.
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 ...
BRUSSELS — The European Union has delayed the introduction ... removing the need to manually stamp passports at the EU's external border. It would require non-EU citizens arriving in the ...
Germany's network regulator confirmed its guidelines for the pricing of postage stamps on Monday, refusing to go beyond its proposed ranges despite protest by the national operator Deutsche Post, ...
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.
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 ...
The European Union will phase out physical passport stamps for most tourists on Nov. 10 when it launches the new Entry/Exit System, which will use a high-tech scanning process to digitally ...
I mean, these slippers speak for themselves. The festive knit! The fur lining! The easy slip-on design! The fact that they're machine washable!! Don't you just wanna throw out all your heels ...
On Friday, Novartis AG (NYSE:NVS) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Kisqali (ribociclib).