Regulation

Clinigen gets EC nod to update product information for Cardioxane

Clinigen Group has secured approval from the European Commission (EC) to update the current product information for Cardioxane.

AbbVie’s Mavyret secures FDA approval for chronic hepatitis C treatment

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 seeks European approval for Axicabtagene Ciloleucel

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 approved in Europe for chronic hepatitis C

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.

CHMP issues positive opinion for Daiichi Sankyo’s LIXIANA label update

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.

FDA rejects Amgen’s BLA for osteoporosis treatment Evenity

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

FDA advisory panel recommends Pfizer’s Mylotarg for acute myeloid leukemia

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 plans to submit NDA to FDA for migalastat for fabry disease

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.

Biohaven’s BHV-5000 secures FDA orphan drug designation for Rett Syndrome

Biohaven Pharmaceutical’s BHV-5000 has been granted orphan drug designation by the US Food and Drug Administration (FDA) for the treatment for patients with Rett syndrome.