Approvals

Progenics’ Azedra gets FDA approval for rare adrenal gland tumors

Progenics Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its radiotherapeutic drug Azedra (iobenguane I 131) to treat rare tumors of the adrenal gland (pheochromocytoma or paraganglioma).

FDA approves Perseris for extended-release injectable suspension to treat schizophrenia in adults

Indivior announced that the US Food and Drug Administration (FDA) has approved Perseris, the first once-monthly subcutaneous risperidone-containing, long-acting injectable (LAI) for the treatment of schizophrenia in adults.

Agios Pharmaceuticals secures FDA nod for leukemia treatment Tibsovo

Agios Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its Tibsovo (ivosidenib) to treat adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation.

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.

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.

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.