Junshi Biosciences/Immorna Joint Venture

Astellas Pharma ’s Vyloy (zolbetuximab) is on track to secure EU-wide approval for treating gastric or gastro-esophageal junction adenocarcinoma, while Ipsen ’s Iqirvo (elafibranor) is poised to rece

Following a protracted regulatory review, the European Medicines Agency is at last due to decide whether to recommend in favor of pan-EU marketing authorization for lecanemab, Eisai / Biogen ’s disea

The US first-approver advantage over the European Union remains stark, with eight of ten novel agents first cleared by the US Food and Drug Administration, according to a Pink Sheet analysis of rece

The US Food and Drug Administration beats the European Medicines Agency to approval of novel agents across the board, but the imbalance is even more stark in oncology, the largest therapy area, a Pin