Approvals

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).

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 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).

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.

Japan’s MHLW approves Olumiant to treat rheumatoid arthritis

Eli Lilly and Company and Incyte announced that Japan's Ministry of Health, Labor and Welfare (MHLW) granted marketing approval for Olumiant (baricitinib) 2-mg and 4-mg tablets for the treatment of rheumatoid arthritis (RA) (including the prevention of structural injury of joints) in patients with inadequate response to standard-of-care therapies.

FDA approves Triptodur to treat central precocious puberty

Arbor Pharmaceuticals and Debiopharm International announced that the US Food and Drug Administration (FDA) has approved Triptodur for the treatment of pediatric patients 2 years and older with central precocious puberty (CPP). CPP occurs when a child shows signs of puberty sooner than normal - before age 8 in girls and 9 nine in boys.

European Commission approves Pfizer’s hard-to-treat leukemia drug Besponsa

Pfizer has secured approval from the European Commission for BESPONSA (inotuzumab ozogamicin) as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).