FDA Approvals

Crizotinib (Xalkori) has been approved for expanded use in patients with metastatic non−small-cell lung cancer (NSCLC) whose tumors have an ROS1 gene alteration, according to an announcement by the US Food and Drug Administration (FDA). The first and only approved treatment for this patient population, crizotinib blocks ROS1 protein activity in tumors, possibly preventing NSCLC from spreading.
The U.S. Food and Drug Administration today approved Xalkori (crizotinib) to treat people with advanced (metastatic) non-small cell lung cancer (NSCLC) whose tumors have an ROS-1 gene alteration.
The U.S. Food and Drug Administration today approved Opdivo (nivolumab) to treat patients with advanced (metastatic) renal cell carcinoma, a form of kidney cancer, who have received a certain type of prior therapy.
The U.S. Food and Drug Administration today approved a new indication for BioThrax (Anthrax Vaccine Adsorbed) to prevent disease following suspected or confirmed exposure to Bacillus anthracis, the bacterium that causes anthrax disease.
Today the U.S. Food and Drug Administration approved Narcan nasal spray, the first FDA-approved nasal spray version of naloxone hydrochloride, a life-saving medication that can stop or reverse the effects of an opioid overdose.
Elotuzumab (Empliciti) (elotuzumab) has been approved for use in combination with lenalidomide (Revlimid) and dexamethasone in patients with multiple myeloma who have received 1 to 3 prior medications. Daratumumab (Darzalex) is the only other US Food and Drug Administration-approved monoclonal antibody for patients with this type of cancer.
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.
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
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