Phase III success for eliglustat tartrate (Sanofi/Genzyme) in Gaucher Disease
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Genentech, a member of the Roche Group announced that the FDA has accepted the company’s Biologics License Application (BLA) and granted Priority Review for mosunetuzumab, a potential first-in-class CD20xCD3 T-cell engaging bispecific antibody, for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic therapies.
Novavax, Inc. announced that the European Commission (EC) has approved the expanded conditional marketing authorization (CMA) of Nuvaxovid (NVX-CoV2373) COVID-19 vaccine in the European Union (EU) for adolescents aged 12 through 17.
NICE (UK) (National Institute for Care and Health Excellence): Pembrolizumab plus chemotherapy (paclitaxel or nab-paclitaxel) is recommended as an option for treating triple-negative, locally recurrent unresectable or metastatic breast cancer in adults who have not had chemotherapy for metastatic disease.