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 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 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 has secured marketing approval from the European Commission for its Cablivi (caplacizumab) to treat adults with acquired thrombotic thrombocytopenic purpura (aTTP).
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 has secured approval from the US Food and Drug Administration (FDA) for its two new HIV-1 treatments, Delstrigo and Pifeltro.
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 has secured the European Commission (EC) approval for its CAR-T cell therapy Kymriah (tisagenlecleucel) for the treatment of B-cell acute lymphoblastic leukemia.
Tetraphase Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its Xerava (eravacycline) to treat complicated intra-abdominal infections (cIAI).
The European Commission (EC) has approved a combination of Xarelto (rivaroxaban) 2.5mg twice daily plus low dose aspirin (acetylsalicylic acid/ASA) once daily for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral arterial disease (PAD) at high risk of ischaemic events.
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