Regulation

CHMP recommends approval of Puma’s breast cancer drug Neratinib

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has reversed its stance on Puma Biotechnology’s breast cancer drug Neratinib by adopting a positive trend vote for its approval in the Europe.

FDA approves Achaogen’s Zemdri to treat adults with cUTI

Achaogen has secured approval from the US Food and Drug Administration (FDA) for its Zemdri (plazomicin) to treat adults with complicated urinary tract infections (cUTI).

FDA approves Greenwich’s marijuana-derived drug for seizures

Greenwich Biosciences, a subsidiary of UK-based GW Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for the Epidiolex (cannabidiol) oral solution to treat seizures associated with two severe childhood-onset epilepsies.

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.

Alexion seeks approval from FDA for PNH drug ALXN1210

Alexion Pharmaceuticals said that it has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA), seeking approval for its C5 complement inhibitor ALXN1210 for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH).

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).