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 has secured approval from the US Food and Drug Administration (FDA) for its TPOXX (tecovirimat) for the treatment of smallpox.
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 has secured regulatory approvals for two major cancer drugs, Imfinzi and Lynparza, in Japan.
AstraZeneca has secured regulatory approvals for two major cancer drugs, Imfinzi and Lynparza, in Japan.
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.
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.
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).
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.
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.
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