FDA APPROVALS

Popular asthma inhaler now expanded to kidsA 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.
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.
Diabetic patients challenge insulin makersIn the latest flap over the high cost of drugs, diabetes patients filed a class-action lawsuit against insulin makers.
Will Trump’s FDA picks speed drug approvals?Three candidates that President Donald Trump is considering for FDA Commissioner are likely to speed drug approvals, analysts say.
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.
Long-acting opioid painkiller wins approvalFDA recently approved a long-acting opioid designed to deter abuse.
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.

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