FDA Updates

The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2015 and are grouped into the following categories. Read More ›

Venetoclax (Venclexta) has been approved by the US Food and Drug Administration (FDA) for daily use in patients with chronic lymphocytic leukemia (CLL) who have 17p deletion, and had ≥1 prior therapies, according to an announcement by the agency. This drug is the first treatment that targets the B-cell lymphoma 2 protein, which is overexpressed in many patients with CLL. Read More ›

Defibrotide sodium (Defitelio) is now US Food and Drug Administration (FDA)-approved for children and adult patients with hepatic veno-occlusive disease (VOD) with added kidney or lung abnormalities following hematopoietic stem cell transplantation (HSCT). This drug is the first to be approved for patients with severe hepatic VOD. Read More ›

Immediate-release opioid analgesics will now require boxed warnings regarding the serious risks for abuse, addiction, overdose, neonatal opioid withdrawal syndrome (NOWS), and death associated with the drugs, according to an announcement by the US Food and Drug Administration (FDA). Read More ›

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. Read More ›

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. Read More ›

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. Read More ›

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. Read More ›

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. Read More ›

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. Read More ›