Approvals

Merck’s Keytruda combo therapy approved in Europe to treat metastatic NSCLC

Merck has secured approval from the European Commission for its anti-PD-1 therapy Keytruda (pembrolizumab) in combination with pemetrexed (ALIMTA) and platinum chemotherapy to treat a type of metastatic nonsquamous non-small cell lung cancer (NSCLC).

Teva secures FDA approval for new dosage strength of Cassipa to treat opioid dependence

Teva Pharmaceuticals USA has secured approval from the US Food and Drug Administration (FDA) for its Cassipa (buprenorphine and naloxone) sublingual film (applied under the tongue) as the maintenance treatment for opioid dependence.

Merck’s Keytruda gets priority review from FDA for Merkel cell carcinoma indication

Merck’s anti-PD-1 therapy Keytruda has been granted priority review designation by the US Food and Drug Administration (FDA) for the treatment of Merkel cell carcinoma.

Sanofi gets EC approval for blood-clotting disorder drug Cablivi

Sanofi has secured marketing approval from the European Commission for its Cablivi (caplacizumab) to treat adults with acquired thrombotic thrombocytopenic purpura (aTTP).

FDA approves Bayer’s Jivi for Hemophilia A patients aged 12 and older

The US Food and Drug Administration (FDA) has approved Jivi (BAY94-9027, antihemophilic factor [recombinant] PEGylated-aucl) for the routine prophylactic treatment of hemophilia A in previously treated adults and adolescents 12 years of age or older.

Merck secures FDA approval for two HIV drugs

Merck has secured approval from the US Food and Drug Administration (FDA) for its two new HIV-1 treatments, Delstrigo and Pifeltro.

EC grants orphan drug status to Trovagene’s Onvansertib for AML treatment

Trovagene has announced that the European Commission (EC) has endorsed the positive opinion of the Committee for Orphan Medicinal Products (COMP) and granted orphan drug designation (ODD) for Onvansertib to treat patients with acute myeloid leukemia (AML).

Novartis’ Kymriah CAR-T cell therapy secures European approval

Novartis has secured the European Commission (EC) approval for its CAR-T cell therapy Kymriah (tisagenlecleucel) for the treatment of B-cell acute lymphoblastic leukemia.

FDA approves Tetraphase’s Xerava for complicated intra-abdominal infections

Tetraphase Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its Xerava (eravacycline) to treat complicated intra-abdominal infections (cIAI).