A1M Pharma AB, of Lund, Sweden

Rosgard

Based on endogenous protein alpha-1-microglobulin

Prevention of acute kidney injury

Swedish Medical Products Agency granted permission for a phase I trial, expected to start in the fist quarter of 2019

Glaxosmithkline plc, of London, and Innoviva Inc., of South San Francisco

Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol)

Triple combination of inhaled corticosteroid, long-acting muscarinic antagonist and long-acting beta2-adrenergic agonist

Chronic obstructive pulmonary disease

European Commission authorized expanded label, recognizing the treatment's effects on exacerbations and clearing it for use in patients with moderate to severe COPD not adequately treated with dual bronchodilation or with an inhaled corticosteroid and a long-acting beta2-agonist

Jazz Pharmaceuticals plc, of Dublin

Solriamfetol

Selective dopamine and norepinephrine reuptake inhibitor

Narcolepsy or obstructive sleep apnea

Submitted MAA to EMA seeking approval to treat wakefulness and reduce excessive daytime sleepiness in adults with narcolepsy, with or without cataplexy, or obstructive sleep apnea

Theravance Biopharma Inc., of Dublin, and Mylan NV, of Hertfordshire, U.K.

Yupelri (revefenacin)

Once-daily nebulized long-acting muscarinic antagonist

Chronic obstructive pulmonary disease

Approved by FDA

Notes

For more information about individual companies and/or products, see Cortellis.