FDA approval

Psoriasis drug approved with boxed warningA new drug to treat moderate-to-severe plaque psoriasis carries a black box warning that suicidal ideas and behavior, including completed suicides, have occurred in patients during the drug’s clinical trials.
Muscular dystrophy drug launch halts after pricing concernsMarathon Pharmaceuticals is temporarily pausing the launch of its drug to treat a rare form of muscular dystrophy (MD) after concerns over its $89,000 price tag.
New bladder cancer, kidney disease therapies availableFDA 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.
The ‘post-truth’ world: How it’s drifting into medicineHenry Rosevear, MD, examines how the political notion of a “post-truth” world has seeped into medicine.
First therapy approved for rare blood cancerFDA recently granted accelerated approved for ibrutinib (Imbruvica, Janssen, Pharmacyclics), the first treatment for patients with a certain type of lymphoma.
Constipation drug wins approvalFDA approved plecanatide (Trulance, Synergy Pharmaceuticals) for adults with chronic idiopathic constipation.
FDA approves hemophilia A drug for childrenFDA recently expanded the use of antihemophilic factor (recombinant), pegylated (Adynovate, Shire plc) for hemophilia A patients under 12 years old.
Advanced ovarian cancer drug approvedFDA recently approved rucaparib (Rubraca, Clovis Oncology) tablets to treat patients with deleterious BRCA mutation (germline and/or somatic)-associated advanced ovarian cancer, who have been treated with 2 or more chemotherapies.
FDA green lights first treatment for rare spinal diseaseFDA 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.
New diabetes combo drug available soonA new combination drug for type 2 diabetes will available in the US in the coming months.