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FDA approves first treatment for excessive night-time urination pharmafile
March 07, 2017
The FDA has approved Noctiva, administered as a nasal spray, for the treatment of people
LSNE Completes Two FDA Inspections cphi-online
March 07, 2017
FDA PAI and general GMP inspection of two aseptic manufacturing plants and QC laboratory completed successfully
US FDA approves Xermelo with SSA therapy to treat carcinoid syndrome diarrhoea pharmaceutical-technology
March 03, 2017
The US Food and Drug Administration (FDA) has approved Lexicon Pharmaceuticals’ Xermelo (telotristat ethyl) tablets in ...
FDA Approves Odactra for House Dust Mite Allergies americanpharmaceuticalreview
March 03, 2017
The U.S. Food and Drug Administration has approved Odactra, the first allergen extract to be administered under the tongue (sublingually) to treat house dust mite (HDM)-induced nasal inflammation (allergic rhinitis), with or without eye inflammation (conj
FDA approves Odactra for house dust mite allergies worldpharmanews
March 02, 2017
The U.S. Food and Drug Administration today approved Odactra the first allergen extract to be administered under the tongue (sublingually) to treat house dust mite (HDM)-induced nasal inflammation (allergic rhinitis).
FDA Approves Xermelo drugs.com
March 01, 2017
FDA Approves Xermelo (telotristat ethyl) as First and Only Oral Treatment for Carcinoid Syndrome Diarrhea in Cancer Patients with Metastatic Neuroendocrine Tumors
FDA Approves Qtern drugs.com
March 01, 2017
FDA Approves Once-Daily Qtern (dapagliflozin and saxagliptin) Tablets for Adults with Type-2 Diabetes
US FDA awards orphan drug designation to Minoryx’s MIN-102 compound pharmaceutical-technology
February 27, 2017
The US Food and Drug Administration (FDA) has granted orphan drug designation to Minoryx Therapeutics’ lead compound MIN-102.
FDA Clears Test to Help Manage Antibiotic Treatment for Lower Respiratory Tract Infections and Sepsi americanpharmaceuticalreview
February 27, 2017
The U.S. Food and Drug Administration has cleared the expanded use of the Vidas Brahms PCT Assay to help health care providers determine if antibiotic treatment should be started or stopped in patients with lower respiratory tract infections, such as comm
US FDA accepts regulatory submission for Pfizer’s inotuzumab ozogamicin pharmaceutical-technology
February 24, 2017
US-based pharmaceutical company Pfizer’s biologics licence application (BLA) for inotuzumab ozogamicin has been accepted for filing and granted priority review by the US Food and Drug Administration (FDA).

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