FDA Updates

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 ›

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 ›

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 ›