The US Food and Drug Administration (FDA) today approved Nucala (mepolizumab) for use with other asthma medicines for the maintenance treatment of asthma in patients aged ≥12 years. Nucala is approved for patients who have a history of severe asthma attacks (exacerbations) despite receiving their current asthma medicines.
The US Food and Drug Administration (FDA) today approved Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for the treatment of human immunodeficiency virus (HIV)-1 infection in adults and pediatric patients aged ≥12 years.
Today the US Food and Drug Administration (FDA) expanded the approved use of Yervoy (ipilimumab) to include a new use as adjuvant therapy for patients with stage III melanoma, to lower the risk that the melanoma will return following surgery.
The US Food and Drug Administration today approved Imlygic (talimogene laherparepvec), the first FDA approved oncolytic virus therapy, for the treatment of melanoma lesions in the skin and lymph nodes.
The US Food and Drug Administration (FDA) today approved Veltassa (patiromer for oral suspension) to treat hyperkalemia, a serious condition in which the amount of potassium in the blood is too high.
The US Food and Drug Administration (FDA) today approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with advanced (metastatic) pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy.
Today, the US Food and Drug Administration (FDA) approved Strensiq (asfotase alfa) as the first approved treatment for perinatal, infantile and juvenile-onset hypophosphatasia (HPP).
The US Food and Drug Administration (FDA) today approved Yondelis (trabectedin), a chemotherapy, for the treatment of specific soft tissue sarcomas (STS)—liposarcoma and leiomyosarcoma—that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who previously received chemotherapy that contained anthracycline.
The US Food and Drug Administration today approved Coagadex, Coagulation Factor X (Human), for hereditary Factor X (10) deficiency. Until today’s orphan drug approval, no specific coagulation factor replacement therapy was available for patients with hereditary Factor X deficiency.
Monmouth Junction, NJ—October 20, 2015—Tris Pharma, Inc. (Tris) announced that the US Food and Drug Administration (FDA) has approved Dyanavel XR (amphetamine), extended­release oral suspension, CII, for the treatment of attention-deficit/ hyperactivity disorder (ADHD) in children aged ≥6 years. With this approval, Dyanavel XR becomes the only once­daily, extended release amphetamine­based oral liquid approved for the treatment of ADHD in children.
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