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.
Shire has secured approval from the US Food and Drug Administration (FDA) for Takhzyro (lanadelumab-flyo) injection as a preventative treatment of hereditary angioedema (HAE) in patients 12 years of age and older.
Dompé has secured approval from the US Food and Drug Administration (FDA) for its Oxervate (cenegermin-bkbj ophthalmic solution) to treat neurotrophic keratitis (NK).
Roche has secured marketing authorization from the China National Drug Administration (CNDA) for its Alecensa (alectinib) as a monotherapy treatment for patients with anaplastic lymphoma kinase (ALK)-positive and advanced non-small cell lung cancer (NSCLC).
The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb's (BMS) Opdivo as the first and only immuno-oncology treatment option for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy.
Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.