FDA recently approved 2 new therapies: an expanded drug indication for locally advanced or metastatic urothelial carcinoma (mUC) and a treatment for secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
In the latest flap over the high cost of drugs, diabetes patients filed a class-action lawsuit against insulin makers.
Three candidates that President Donald Trump is considering for FDA Commissioner are likely to speed drug approvals, analysts say.
FDA recently granted accelerated approved for ibrutinib (Imbruvica, Janssen, Pharmacyclics), the first treatment for patients with a certain type of lymphoma.
FDA approved plecanatide (Trulance, Synergy Pharmaceuticals) for adults with chronic idiopathic constipation.
FDA recently approved a long-acting opioid designed to deter abuse.
FDA recently expanded the use of antihemophilic factor (recombinant), pegylated (Adynovate, Shire plc) for hemophilia A patients under 12 years old.
While FDA approved far fewer new drugs in 2016 than 2015, the agency quickly approved novel and breakthrough therapies.
FDA approved nusinersen (Spinraza, Biogen), the first drug to treat children and adults with spinal muscular atrophy (SMA), a rare and often fatal genetic disease affecting muscle strength and movement.