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The third time is the charm for AstraZeneca and its hyperkalemia treatment that has been dogged by manufacturing issues. After multiple rejections, the U.S. Food and Drug Administration finally gave its approval for the treatment.
Nabriva Therapeutics reported positive topline results from its Phase III clinical trial of oral lefamulin compared to oral moxifloxacin in adults with moderate community-acquired bacterial pneumonia (CABP).
Genentech’s hemophilia treatment Hemlibra continues to demonstrate its efficacy in treating patients. New late-stage data presented at World Federation of Hemophilia 2018 World Congress shows the drug significantly reduced treated bleeds in a broad patient population in two separate studies.
Avenue Therapeutics, announced its Phase III clinical trial of IV tramadol hit its primary endpoint of statistically significant improvement.
Amgen and Novartis scored a big win in the migraine market late Thursday when the U.S. Food and Drug Administration approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults.
In order to drive the manufacture of affordable generic drugs, the U.S. Food and Drug Administration is naming names of companies that have attempted to block competition.
Concerns regarding favoritism to a former commissioner have forced the U.S. Food and Drug Administration to reverse course over a $4.2 million grant to Duke University.
Wednesday was the big day for pharma and biotech companies to unveil abstracts ahead of the annual American Society of Oncology meeting in Chicago next month. Some companies have unveiled positive results that are making investors happy, while others… not so much.
U.S. Food and Drug Administration approved a new treatment to help patients manage withdrawal symptoms from opioid addiction.
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