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Approvals, Launches, and New Indications

Recurrence-free survival superior to Yervoy in trial
Pfizer drug was previously indicated as second-line therapy
Approval granted well in advance of predicted PDUFA date
Luxturna is first gene therapy to target a disease caused by mutations in a specific gene
Drug lowers intraocular pressure in open-angle glaucoma or ocular hypertension
Cream targets Staphylococcus aureus and Streptococcus pyogenes
The company, which already sells Inflectra, got Ixifi in Hospira purchase
Manufacturer used FDA’s 505(b)(2) abbreviated approval pathway
This is the first drug for patients with eosinophilic granulomatosis with polyangiitis
Platform offers advanced technology to treat symptoms of Parkinson’s disease
Once-weekly GLP-1 receptor agonist to be available in early 2018
Second approved indication for Taltz in the United States
Evolocumab is the first PCSK9 Inhibitor to win this indication
Mylan’s new product will treat breast and stomach cancer
Medication-assisted treatment option tackles opioid use disorder
Fine-tuning implanted lens may help some patients skip eyeglasses
New combo is a maintenance treatment for virologically suppressed HIV-1
Needle length and dose target patients weighing 16.5 to 33 pounds
Patients can avoid long drives to distant specialists