Regulation

Alliance Pharma secures UK approval for nausea drug Diclectin

Alliance Pharma has secured approval for Diclectin in the UK from the Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of nausea and vomiting in pregnant women.

EMA accepts Clovis’ application for expanded indication of Rubraca to treat ovarian cancer

The European Medicines Agency (EMA) has accepted Clovis Oncology’s marketing application for a new indication of Rubraca (rucaparib) as maintenance treatment for women with recurrent ovarian cancer.

AstraZeneca gets regulatory approvals for two cancer drugs in Japan

AstraZeneca has secured regulatory approvals for two major cancer drugs, Imfinzi and Lynparza, in Japan.

AstraZeneca gets regulatory approvals for two cancer drugs in Japan

AstraZeneca has secured regulatory approvals for two major cancer drugs, Imfinzi and Lynparza, in Japan.

FDA approves Array BioPharma’s Braftovi/Mektovi melanoma combo treatment

The US Food and Drug Administration (FDA) has approved Array BioPharma’s oral combination treatment of Braftovi (encorafenib) capsules and Mektovi (binimetinib) tablets for a serious and deadly type of skin cancer.

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.