Regulatory
Companies from across the globe provide information on agreements and pipeline updates.
Immigration has been a central concern of President Donald Trump. Since taking office, his administration has put forth a number of policies to restrict the number of immigrants allowed each year, as well as from what nations those immigrants can come.
Retrophin, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved 100 mg and 300 mg tablets of THIOLA® EC (tiopronin), a new enteric-coated formulation of THIOLA® (tiopronin), to be used for the treatment of cystinuria, a rare inherited disorder that causes a buildup of cystine levels in the urine resulting in the formation of recurring cystine kidney stones.
FDA Quality and Regulatory Consultants and its sister company, Solar Compliance have announced a unique tool to help in the due diligence and qualification of outsourced partners, The Orange Report.
Retrophin, based in San Diego, announced that the U.S. Food and Drug Administration (FDA) had given its 100 mg and 300 mg tablets of Thiola EC (tiopronin) the thumbs-up to treat cystinuria.
National Cancer Control Efforts Should Address the System, Not Its Individual Parts, Says New Report
Current cancer control efforts in the United States typically are fragmented and uncoordinated, but taking a systems approach to establish a U.S. National Cancer Control Plan would address the challenge more holistically, says a new report from the National Academies of Sciences, Engineering, and Medicine.
Polarean Imaging plc, the clinical stage medical-imaging technology company, with a proprietary drug-device combination product for the visualisation of pulmonary function in the magnetic resonance imaging market, announces its audited final results for the year ended 31 December 2018.
In April, the U.S. Food and Drug Administration (FDA) issued a Refuse to File (RTF) letter to Zogenix for its New Drug Application (NDA) for Fintepla (fenfluramine hydrochloride).
Clinical data showed Dupixent reduces nasal polyp size, improves congestion and loss of smell, while reducing the need for surgery and systemic corticosteroids.
BioTek’s Synergy™ Neo2 Hybrid Multi-Mode Microplate Reader received expanded certification from Cisbio Bioassays for their proprietary HTRF® technology, a TR-FRET assay platform used in the Life Sciences.
PRESS RELEASES