Theravance Biopharma‘s (NSDQ:TBPH) said today that the FDA granted expanded indications for GlaxoSmithKline‘s (NYSE:GSK) Trelegy Ellipta inhaler, now approved for use to treat a broader population of chronic obstructive pulmonary disease patients. With the expansion, the inhaler is now cleared for COPD patients with airflow limitations and for those who have experienced an acute worsening of […]
The FDA has accepted Theravance Biopharma‘s (NSDQ:TBPH) marketing application for revefenacin, an inhaled long-acting muscarinic antagonist designed to treat chronic obstructive pulmonary disease. The FDA is slated to make a decision about the once-daily treatment by Nov. 13. Get the full story at our sister site, Drug Delivery Business News.
Mylan (NSDQ:MYL) and Theravance Biopharma, Inc. (NSDQ:TBPH) touted safety data yesterday from the late-stage trial of its once-daily inhaled bronchodilator, revefenacin, in patients with chronic obstructive pulmonary disease. If approved, revefenacin would be the first nebulized long-acting muscarinic antagonist on the market for COPD patients in the U.S. Get the full story at our sister site, Drug Delivery Business […]
Mylan (NSDQ:MYL) and Theravance Biopharma, Inc. (NSDQ:TBPH) said today that revefenacin, the 1st nebulized bronchodilator in development for the treatment of chronic obstructive pulmonary disease(COPD), demonstrated positive results in 2 replicate phase III efficacy studies. Data from more than 1,250 moderate to severe COPD patients show that both studies met their efficacy and safety endpoints. […]