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Approvals, Launches, and New Indications

FDA permits marketing of Viz.AI Contact to speed treatment
Manufacturing problems caused million-dollar delay
With extended-release dexamethasone, patients can avoid weeks of drops
Gilead tablet contains bictegravir, emtricitabine, and tenofovir alafenamide
New FDA indication comes in combination with prednisone
Moderate-to-severe scalp psoriasis is difficult to treat
Wearable device identifies convulsive epileptic seizures and sends alerts to caregivers
Targeted treatment includes a radioactive component
FDA adds a second indication for the medication
Vaccine was previously approved for patients older than 3 years of age
First PARP inhibitor to receive FDA approval for use beyond ovarian cancer
Drug previously limited to those with solid tumors
Valsartan was first FDA-approved in 2001 as Diovan tablets
The minimally invasive technology is a synthetic, resorbable bone-graft substitute
The noninvasive technology is used in conjunction with breast-conserving treatment
Agent increases BP in adults with septic or other distributive shock
An SGLT2 inhibitor and two fixed-dose combinations will be available in January and February 2018
Accelerated approval for neoadjuvant use also converted to full approval