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The FDA has granted a priority review to Sanofi’s biologics license application (BLA) for an experimental enzyme replacement therapy for patients suffering from Pompe disease, a rare illness that causes muscle deterioration and reduced lung capacity. Read More
The European Commission has approved AstraZeneca’s leukemia drug Calquence (acalabrutinib) for the treatment of adults with chronic lymphocytic leukemia (CLL). Read More
Adicet has won Investigational New Drug clearance from the FDA for ADI-001, a chimeric antigen receptor (CAR) gamma delta T-cell therapy for nonHodgkin’s lymphoma. Read More
The FDA on Thursday granted full approval to Gilead Sciences’ Veklury (remdesivir) to treat hospitalized COVID-19 patients, making it the first approved COVID-19 treatment in the U.S. Read More
Agios has withdrawn its EU marketing authorization application to the European Medicines Agency for Tibsovo (ivosidenib) for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) featuring an isocitrate dehydrogenase-1 (IDH1) mutation. Read More