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.
AbbVie’s maviret (glecaprevir/pibrentasvir) has secured the approval of the European Commission for the treatment of chronic hepatitis C virus (HCV) infection in all major genotypes from GT1 to GT6 in adult patients.
The European Committee for Medicinal Products for Human Use (CHMP) has recommended approval of a label update for Daiichi Sankyo Europe's LIXIANA, to provide guidance on its use in patients undergoing transoesophageal echocardiography (TEE)-guided and delayed cardioversion.
The US Food and Drug Administration (FDA) has rejected Amgen and UCB’s biologics license application (BLA) for Evenity (romosozumab) to treat postmenopausal women with osteoporosis
Pfizer’s Mylotarg (gemtuzumab ozogamicin) has been recommended for approval by the US Food and Drug Administration’s (FDA) Oncologic Drug Advisory Committee (ODAC) to treat acute myeloid leukemia (AML).
Amicus Therapeutics has revealed its plans to file a new drug application (NDA) with the US FDA for the oral precision medicine migalastat for Fabry disease in the fourth quarter of the year.
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