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Approvals, Launches, and New Indications

Approved as Maintenance Treatment for Opioid Dependence
Orphan Drug May Provide Complete Corneal Healing in Some Patients
Battle of the Auto-Injectors May Lead to Lower Costs for Patients
Venous Thromboembolism and Other Risks to Be Evaluated in Postmarketing Studies
First Oral Drug Increases Activity of the Body’s Deficient Enzyme
Radiation Exposure Remains a Risk
The move is considered part of the antiterrorism effort.
Epidiolex is indicated for rare, severe forms of epilepsy
Patients as young as 7 years of age may now use the device for their type-1 diabetes
Sensor alerts adults with diabetes of high or low glucose levels via smartphone or tablet
However, patent dispute will delay one launch
Approval acquired through tropical disease priority review voucher program
Therapy approved for adults and children with refractory PMBCL or who have relapsed after two or more prior lines of therapy
Continuous nerve stimulation helps to alleviate withdrawal symptoms
Agent decreases the chance of infection due to chemo-induced febrile neutropenia
Drug now approved for moderately to severely active ulcerative colitis
Novel enzyme therapy is for adults with PKU who have uncontrolled blood phenylalanine concentrations with current treatment

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