In addition to AVT06, which is a biosimilar candidate for Eylea ® (aflibercept) 2 mg, Alvotech is currently also developing AVT29, a biosimilar candidate for Eylea ® HD (aflibercept) 8 mg. Teva also ...

The European Commission has adopted legislation requiring EU countries to do Whole Genome Sequencing (WGS) during foodborne ...

Priority Review Vouchers (PRVs) are transferable and, in past transactions by other companies, have sold for prices up to $350 million1.3 to 4 ...

AI companies in the US operate within a complex regulatory landscape shaped by multiple agencies and industry-specific laws.

Eisai and Biogen have moved swiftly ahead with regulatory filings for their new Alzheimer's therapy lecanemab in the EU, after getting ... application with the FDA, that will try to covert the ...

In response to this growing health crisis, nine EU-backed projects have joined forces in an unprecedented collaborative effort, leading to the formation of OBEClust: the European Cluster of ...

Regeneron's CD20xCD3 bispecific antibody for non-Hodgin lymphoma (NHL) has been approved in Europe, five months after it was turned down by the FDA in the ... cleared in the EU for the same ...

EssilorLuxottica has received approval in the US and EU to market its Nuance audio glasses, a device that combines hearing solutions with prescription lenses. According to a 3 February press ...

The U.S. Food and Drug Administration has made an update to its MadeGood granola bar recall. The popular granola bars, sold on Amazon and in stores like Target, Whole Foods, Wegmans, CVS, among ...

The new EU project COMBINE ("Comparative Signature of Marburg Virus Cell Activation as a Blueprint for the Identification of Antiviral Targets against Newly Emerging Viruses") acknowledges that ...