Diana Ernst

RPh

Most Recent Articles by Diana Ernst

Tiotropium Bromide and Olodaterol Labeling Updated With Revised Indication

Tiotropium Bromide and Olodaterol Labeling Updated With Revised Indication

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The FDA has approved updated labeling for Stiolto Respimat to include COPD exacerbation data and a revised indication.

Omadacycline Approved for Community-Acquired Bacterial Pneumonia

Omadacycline Approved for Community-Acquired Bacterial Pneumonia

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The FDA has approved Nuzyra for the treatment of adult patients with CABP and acute bacterial skin and skin structure infections.

Arikayce Approved to Treat <i>Mycobacterium Avium</i> Complex Lung Disease

Arikayce Approved to Treat Mycobacterium Avium Complex Lung Disease

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Arikayce is intended for oral inhalation use and is administered via the Lamira Nebulizer System only.

Xolair Prefilled Syringe Formulation Gets FDA Approval

Xolair Prefilled Syringe Formulation Gets FDA Approval

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The PFS formulation eliminates the need to reconstitute the solution before administration.

Vizimpro Approved as First-Line Treatment for EGFR-Mutated Metastatic NSCLC

Vizimpro Approved as First-Line Treatment for EGFR-Mutated Metastatic NSCLC

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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).

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