Approved Label News Today

Transgene Expands Phase II Clinical Trial of Therapeutic Vaccine TG4001 in Combination With Avelumab Versus Avelumab Monotherapy in Patients With HPV16-positive Anogenital Cancers - Trial will focus on patients without liver metastases, based on encouraging data in Phase Ib/II study - Trial targets indications where clinical outcomes can be improved versus standard therapeutic options and immune checkpoint inhibitors ("ICIs") - Continued clinical collaboration with Merck KGaA, Darmstadt, Ger...

(PRNewsfoto/EMD Serono) ROCKLAND, Mass. and NEW YORK, Jan. 25, 2021 /PRNewswire/ -- EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has approved BAVENCIO ® (avelumab) as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy. "A...

EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada and Pfizer Inc. today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending approval of BAVENCIO ® as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma who … – EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Ger...