Most Recent Articles by Diana Ernst
The FDA has approved updated labeling for Stiolto Respimat to include COPD exacerbation data and a revised indication.
The FDA has approved Nuzyra for the treatment of adult patients with CABP and acute bacterial skin and skin structure infections.
Arikayce is intended for oral inhalation use and is administered via the Lamira Nebulizer System only.
The PFS formulation eliminates the need to reconstitute the solution before administration.
The approval was based on data from the ARCHER 1050 open-label, active controlled study which randomized patients with unresectable, metastatic NSCLC to treatment with either dacomitinib (N=227) or gefitinib (N=225).