Sunovion Pharmaceuticals announced that it has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for dasotraline, a novel investigational, dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI), for the treatment of children, adolescents and adults with attention deficit hyperactivity disorder (ADHD).
Novartis has secured approval from the US Food and Drug Administration (FDA) for its Kymriah (tisagenlecleucel or CTL019) to treat children and young adults with B-cell precursor acute lymphoblastic leukemia (ALL).
Merck announced that the European Commission (EC) has granted marketing authorization for Mavenclad 10mg (Cladribine Tablets) for the treatment of highly active relapsing multiple sclerosis*(RMS) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland.
Novartis’ breast cancer drug Kisqal has secured authorisation from the European Commission for the treatment of advanced breast cancer.
Alexion Pharmaceuticals announced that the European Commission (EC) approved the extension of the indication for Soliris (eculizumab) to include the treatment of refractory generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive.
Seattle Genetics reported that the US Food and Drug Administration (FDA) has accepted for filing a supplemental Biologics License Application (BLA) based on data from the phase 3 ALCANZA trial and two phase 2 trials of ADCETRIS (brentuximab vedotin) in patients with cutaneous T-cell lymphoma (CTCL).
The US Food and Drug Administration (FDA) has granted orphan drug designation for H3 Biomedicine's H3B-8800, its lead clinical compound for the treatment of patients with Acute Myelogenous Leukemia (AML) and Chronic Myelomonocytic Leukemia (CMML).
Clinigen Group has secured approval from the European Commission (EC) to update the current product information for Cardioxane.
The US Food and Drug Administration (FDA) has approved AbbVie's Mavyret (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment has been approved by for treating adult patients with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6).
Kite Pharma has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for axicabtagene ciloleucel as a treatment for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) who are not eligible for autologous stem cell transplant.
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