Regulatory
The company disclosed late Monday that the U.S. Food and Drug Administration placed a clinical hold on its proposed gene therapy treatment for methylmalonic academia.
Linshom announced U.S. Food and Drug Administration 510 clearance of the company’s first product, a small, non-invasive respiratory monitor that addresses the growing need for continuous respiratory monitoring for patients susceptible to respiratory depression and compromise.
“The FDA filing acceptance for Libervant is an important milestone in our mission to provide epilepsy patients with a broader array of treatment options, that represent major contributions to patient care,” said Keith J. Kendall, Aquestive’s chief executive officer.
Myovant to Seek Regulatory Approval of Uterine Fibroid Treatment Following Positive Late-Stage Trial
More than five million women suffer from symptoms of uterine fibroids, with more than half of them estimated to have received inadequate treatment. However, new data released by Myovant shows that concerns of inadequate treatment could soon change.
Pharma and life science companies from across the globe provide updates on their pipelines and businesses.
Unique feature of bioSens-All™ technology enables discovery of therapeutics for pathologies linked to GPCR mistrafficking
Following a court’s ruling last week over a partial clinical hold placed on the company in 2018 by the U.S. Food and Drug Administration, Vanda Pharmaceuticals said it is undertaking a “comprehensive review” of the decision and will then determine the next appropriate steps.
MedAlliance has announced the award of its first CE Mark approval: for SELUTION SLR™, a novel Sirolimus Drug Eluting Balloon, for the treatment of peripheral arterial disease.
GBA Group Pharma has informed its industry partners and clients on risks to their clinical trial plans caused by Brexit and is highlighting the significant business difficulties for healthcare companies running clinical trials through UK-based organisations.
Audenz is the first-ever adjuvanted, cell-based influenza vaccine designed to protect against influenza A (H5N1) in the event of a pandemic.
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