Bellerophon Therapeutics announced positive topline results from cohort 2 of a study of INOpulse delivery system for PH-ILD.
The FDA has approved Tecentriq in combination with chemotherapy (Abraxane [paclitaxel protein-bound, nab-paclitaxel; Celgene] and carboplatin) for the first-line treatment of adults with metastatic NSCLC with no EGFR or ALK genomic tumor aberrations.
Vanco Ready, a ready-to-use (RTU) vancomycin injection, has been made available by Xellia Pharmaceuticals.
The primary end point was the reduction in the percentage of subjects with clinically symptomatic respiratory illness, defined as illness associated with a respiratory tract infection based on prespecified diagnostic criteria, with or without laboratory confirmation of a pathogen.
GSK announced positive results from the pivotal phase 3 study of mepolizumab in the treatment of patients with hypereosinophilic syndrome.
The FDA has issued a warning letter to Greenbrier International for receiving OTC drugs produced by foreign manufacturers with multiple violations of current good manufacturing practices.
A new cheek swab, known as AlphaID (Grifols), has been made available for physicians to screen patients with chronic obstructive pulmonary disease (COPD) for alpha-1 antitrypsin deficiency (Alpha-1).
The FDA has approved the supplemental Biologics License Application (sBLA) for Fluzone High-Dose Quadrivalent for active immunization for the prevention of influenza disease in patients aged ≥65 years.
The FDA has approved the supplemental NDA for Baxdela for the treatment of community acquired bacterial pneumonia in adult patients.