Approvals

FDA approves label expansion for Shire’s HAE drug Cinryze

Shire has secured a label expansion from the US Food and Drug Administration (FDA) for its hereditary angioedema (HAE) therapy Cinryze to help prevent angioedema attacks in HAE-affected children, aged 6 years and older.

ImmunoGen gets FDA fast track status for mirvetuximab soravtansine to treat platinum-resistant ovarian cancer

ImmunoGen has secured fast track designation from the US Food and Drug Administration (FDA) for its lead program, mirvetuximab soravtansine.

Ascletis’ Ganovo gets CFDA approval for treatment of viral hepatitis C

The China Food and Drug Administration (CFDA) has approved Ascletis' Category 1 new drug, Ganovo (Danoprevir or ASC08), for the treatment of viral hepatitis C.

Merck’s Keytruda secures FDA approval for advanced cervical cancer

The US Food and Drug Administration (FDA) has expanded the approval of Merck's anti-PD-1 therapy Keytruda (pembrolizumab) for the treatment of recurrent or metastatic cervical cancer in patients whose disease had progressed on or after chemotherapy.

Genentech’s Rituxan gets FDA approval to treat pemphigus vulgaris

Genentech, a subsidiary of Roche, has secured approval from the US Food and Drug Administration (FDA) for its antibody therapy Rituxan (rituximab) to treat adults with moderate to severe pemphigus vulgaris (PV).

Roche’s Hemlibra gets FDA priority review for new haemophilia A indication

Roche’s Hemlibra (emicizumab) has been granted priority review by the US Food and Drug Administration (FDA) for the treatment of haemophilia A without factor VIII inhibitors in both adults and children.

European Commission approves Perjeta and Herceptin combo

The European Commission (EC) has approved Roche’s Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen) for post-surgery treatment of adults with HER2-positive early breast cancer (eBC) at high risk of recurrence.

Lilly and Incyte gain FDA approval for lower dose of RA drug Olumiant

The US Food and Drug Administration (FDA) has approved a lower dose of Olumiant (baricitinib), a daily once oral Janus kinase (JAK) inhibitor developed by Lilly and Incyte to treat moderately-to-severely active rheumatoid arthritis (RA).

Pfizer’s Xeljanz gets FDA approval for ulcerative colitis

Pfizer’s Janus kinase (JAK) inhibitor Xeljanz (tofacitinib) has been approved by the US Food and Drug Administration (FDA) to treat adult patients with moderately to severely active ulcerative colitis.