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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).
US FDA grants fast-track designation to Cell Medica's CMD-003 pharmaceutical-technology
February 23, 2017
The US Food and Drug Administration (FDA) has granted fast-track designation to UK-based cellular immunotherapy firm Cell Medica's oncology product CMD-003 (baltaleucel-T).
FDA rejects Amphastar's filing for intranasal naloxone as opioid overdose treatment firstwordpharma
February 22, 2017
Amphastar Pharmaceuticals announced Tuesday that the FDA issued a complete response letter regarding the company's filing seeking approval of intranasal naloxone for the emergency treatment of known or suspected opioid overdose.
FDA Approves Perrigo’s Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution americanpharmaceuticalreview
February 22, 2017
Perrigo Company has received final approval from the U.S. Food and Drug Administration for hydrocodone bitartrate and homatropine methylbromide oral solution (syrup), 5 mg/1.5 mg per 5 mL.
World's first health monitoring system in a smartphone ready for FDA approval biospectrumasia
February 21, 2017
Blood pressure and other vital signs system accuracy already proven in trials
FDA to review Mylan and Biocon’s biosimilar application europeanpharmaceuticalreview
February 20, 2017
The US Food and Drug Administration (FDA) has accepted Mylan and Biocon‘s biologics license application for MYL-1401H, a proposed biosimilar to Neulasta (pegfilgrastim).
FDA approves Valeant's Siliq for plaque psoriasis firstwordpharma
February 17, 2017
The FDA announced the approval of Valeant Pharmaceuticals' Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis.
FDA Expands Approval of SPIRIVA® RESPIMAT® Inhalation Spray for Maintenance Treatment of Asthma in C americanpharmaceuticalreview
February 17, 2017
Boehringer Ingelheim Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) approved SPIRIVA RESPIMAT for the long-term, once-daily maintenance treatment of asthma in people age 6 and older.
FDA Accepts Biologics License Application (BLA) for Mylan and Biocon's Proposed Biosimilar Pegfilgra americanpharmaceuticalreview
February 17, 2017
Mylan and Biocon announced that the U.S. Food and Drug Administration (FDA) has accepted Mylan's Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar to Neulasta® (pegfilgrastim), for filing through the 351(k) pathway.

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