Regulation

SIGA Technologies gets FDA nod for TPOXX to treat smallpox

SIGA Technologies has secured approval from the US Food and Drug Administration (FDA) for its TPOXX (tecovirimat) for the treatment of smallpox.

EMA recalls certain heart drugs containing valsartan over safety fears

The European Medicines Agency (EMA) has recalled certain heart drugs containing valsartan across the European Union (EU) over possible contamination with a cancer-causing substance.

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).