FDA Approvals, News & Updates

The FDA approved sonidegib for all patients with locally advanced basal-cell carcinoma (BCC).
Ixazomib (Ninlaro) has been approved for use in combination with lenalidomide (Revlimid) and dexamethasone in patients with multiple myeloma who have received ≥1 prior therapy. The drug is the first orally-administered proteasome inhibitor
Today the U.S. Food and Drug Administration granted accelerated approval for Darzalex (daratumumab) to treat patients with multiple myeloma who have received at least three prior treatments.
The U.S. Food and Drug Administration today approved Adynovate, Antihemophilic Factor (Recombinant), PEGylated for use in adults and adolescents, aged 12 years and older, who have Hemophilia A
It is no secret that developing cancer drugs is a time-consuming and costly endeavor. Although the US Food and Drug Administration (FDA) review represents only a fraction of the entire timeline, accelerated evaluation can still shave years off this process.
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.
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