FDA Approvals

Today, the US Food and Drug Administration (FDA) granted accelerated approval for an oral medication to treat patients with advanced non—small-cell lung cancer (NSCLC).
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.
The US Food and Drug Administration (FDA) today approved Cotellic (cobimetinib) to be used in combination with vemurafenib to treat advanced melanoma.
The US Food and Drug Administration (FDA) today approved Genvoya 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 (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.
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.
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 (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.
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).
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