A 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.
A leading asthma inhaler will now be available to additional younger asthma patients, after FDA approved Spiriva Respimat (Boehringer Ingelheim) for the long-term, once-daily maintenance treatment of asthma in people age 6 and older.
Marathon 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.
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.
McKesson Corp., one of the largest distributors of pharmaceuticals, agreed to pay a record civil penalty for alleged violations of the Controlled Substances Act.
FDA approved plecanatide (Trulance, Synergy Pharmaceuticals) for adults with chronic idiopathic constipation.
FDA recently approved a long-acting opioid designed to deter abuse.