FDA Updates

Necitumumab (Portrazza) has been approved in combination with 2 forms of chemotherapy for patients with metastatic, squamous non–small-cell lung cancer (NSCLC) who have not received previous treatment for their cancer. Read More ›

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 Read More ›

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. Read More ›

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 Read More ›

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. Read More ›

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). Read More ›

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. Read More ›

The US Food and Drug Administration (FDA) today approved Cotellic (cobimetinib) to be used in combination with vemurafenib to treat advanced melanoma. Read More ›

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. Read More ›

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. Read More ›

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