FDA Clearance: Syntr Health Technologies SyntrFuge System
Syntr Health Technologies has been granted clearance from the US FDA (Food and Drug Administration) for their SyntrFuge System for surgical use when transferring a patient’s adipose (fat) tissue. Syntr Health Technologies, a medical device company that focuses on the...
Akouos AK-OTOF Receives Positive Statement From EMA For ODD
The European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has given a positive opinion on Akousos application for orphan drug designation for AK-OTOF. Akouos, a precision genetic medicine company which aims to produce gene therapies for people...
ACC Finds Women Still Under-represented in Cardiology Trials
The American College of Cardiology (ACC) Cardiovascular Disease in Women Committee released a new report concluding that women, particularly women of color and minority women are still under-represented in a large majority of clinical cardiology (CVD) trials, in spite...
ICMRA Issues Guidelines for Global Track and Trace Systems
The International Coalition of Medicines Regulatory Authorities (ICMRA) has released comprehensive guidelines recommending how regulatory bodies can introduce aligned track and trace systems around the world to combat counterfeit or falsified products in global supply...
FDA Approves Sanofi’s Nexviazymefor to Treat Pompe Disease
The US FDA (Food and Drug Administration) has approved Sanofi’s Nexviazymefor to treat patients with rare but potentially fatal muscle disorder, Pompe disease. Pompe disease affects 1 in 40,000 Americans and weakens the heart and skeletal muscles caused by an...
Ardelyx Tenapanor Approval Requires Further Clinical Study
The US Food and Drug Administration (FDA) has rejected Tenapanor for Control of Phosphorus in Kidney Disease, asking for another clinical trial that indicates the drug’s greater benefits before approval. Ardelyx devleoped Tenapanor, an oral inhibitor of the...