Approvals

Novartis gets FDA nod for cancer treatment Kymriah

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).

European Commission grants approval for Mavenclad

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.

European Commission approves Novartis breast cancer drug Kisqali

Novartis’ breast cancer drug Kisqal has secured authorisation from the European Commission for the treatment of advanced breast cancer.

EC grants new indication for Soliris to treat refractory generalized myasthenia gravis

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 gets FDA priority review for Adcetris in Cutaneous T-Cell Lymphoma

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).

H3 Biomedicine gets FDAorphan drug status for acute myelogenous leukemia treatment

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 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.