Three biopharma drugs are up for FDA approval this week, including one new chemical entity, dasotraline, from Sunovion Pharmaceuticals Inc. to treat binge eating disorder, and two other candidates that are part of supplemental filings for expanded indications.
HONG KONG – South Korea’s Hanmi Pharmaceutical Co. Ltd. has filed a new drug approval application for Rolontis (eflapegrastim) with the country’s Ministry of Food and Drug Safety (MDFS).
About 15 months after closing its multibillion-dollar acquisition of Loxo Oncology Inc., Eli Lilly and Co. has secured an accelerated FDA approval for the first of the deal's headline assets, the RET kinase inhibitor selpercatinib, now branded as Retevmo.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 9 Meters, Appili, Astrazeneca, Bellerophon, Crispr, Daiichi, Histogen, Lilly, Merck, Relief, Tracon, Vertex.
The U.S. FDA’s enforcement regarding products related to the COVID-19 pandemic has picked up steam recently, but the U.S. Federal trade commission (FTC) is also involved in this enforcement arena. Leonard Gordon, a partner at Venable LLP’s New York office, told BioWorld that while the FTC and FDA missions seem to overlap, the FTC primarily targets unsupportable advertising claims rather than product labeling, a particularly relevant area in the COVID-19 pandemic.
PERTH, Australia – As New Zealand and Australia prepare to open their economies, regulators in these two neighboring countries are taking very different approaches to regulating COVID-19 devices with New Zealand restricting point-of-care tests, while Australia imposes tougher postmarket activities.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Bedfont Scientific, Philosys, Rutgers Clinical Genomics Laboratory, Spectrum Solutions, University of Kentucky.
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