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October 18, 2021
The agency cited an open inspection issue at a facility that performs analytical testing of drug substance.
July 08, 2021
The agency also granted tezepelumab priority review with a PDUFA date sometime in the first quarter of 2022.
June 10, 2019
The first respiratory biologic to be approved for administration via an autoinjector will be available in the US soon.
June 17, 2011
Budesonide/Formoterol maintenance and reliever therapy is an effective option for patients requiring treatment adjustments across Steps 2 to 4 of the Global Initiative for Asthma guidelines, according to the results of a study published online, June 2 in Respiratory Research.
June 10, 2011
Use of short- and long-acting inhaled anticholinergic medications in men with chronic obstructive pulmonary disease is associated with an increased risk of acute urinary retention, according to the results of a study published in the May 23 issue of Archives of Internal Medicine.
May 27, 2011
Pirfenidone, an investigational drug (InterMune) that inhibits the synthesis of TGF-beta and TNF-alpha, was associated with positive effects on lung function, 6-minute walk test distance, and progression-free survival in patients with mild-to-moderate idiopathic pulmonary fibrosis, according to a study published in The Lancet.
May 18, 2011
For the fourth consecutive year, diabetes therapy topped the list of contributors to drug use trends in therapeutic categories, contributing 16.1% to overall growth in drug spending in 2010 due to an increasing number of patients, according to the recently released 2011 Medco Drug Trend Report, which tracks utilization and spending.
May 01, 2011
New molecular entity: Roflumilast oral treatment was approved by FDA as treatment to reduce risk of COPD exacerbations.
April 08, 2011
The anticholinergic drug tiotropium is more effective than the ?2-agonist salmeterol in preventing exacerbations in patients with moderate-to-very-severe chronic obstructive pulmonary disease, according to a multicenter European study published in the New England Journal of Medicine.
May 01, 2009
New indication: Tigecycline (Tygacil), a tetracycline-class antibiotic, was approved on March 20, 2009, for the treatment of community-acquired bacterial pneumonia
