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MPR Drug News

Simponi Aria Approved for Psoriatic Arthritis, Ankylosing Spondylitis

The FDA's expanded approvals were supported by data from two Phase 3 multicenter, randomized, double-blind, placebo-controlled studies (GO-VIBRANT and GO-ALIVE) that included >600 patients.

Bydureon BCise Gets FDA Approval for Type 2 Diabetes

In clinical trials, treatment with Bydureon BCise resulted in average HbA1c reductions of up to 1.4% and average weight loss of up to 3.1 pounds when used as monotherapy or as an add-on to metormin, a sulfonylurea, a thiazolidinedione, or any combination of two of these agents, at 28 weeks.

FDA Approves Shingrix for Prevention of Shingles

The use of Shingrix also decreased the overall incidence of postherpetic neuralgia (PHN).

Voluntary Market Withdrawal of Octagam 10% Announced

The Company has decided in conjunction with the FDA to suspend further administration of Octagam 10% from these specific production lots.

FDA Clears First Smartphone Compatible Insertable Cardiac Monitor

Patients can also track and monitor their heart rhythms at any time and view the history of their clinician transmissions without having to contact their clinic.