Rocket to Resume Clinical Trial following FDA Hold Lift
The US FDA (Food and Drug Administration) has lifted their clinical hold on Rocket Pharmaceuticals for their experimental gene therapy program for the treatment of Danon disease. Following the decision, Rocket announced it will resume patient enrollment later this...
CytoDyn HIV Justification Report: Guidance From FDA
The U.S FDA (Food and Drug Administration) has provided CytoDyn with guidance on its recent HIV BLA dose justification report, a crucial part of the company’s resubmission for its Biologics License Application (BLA) for HIV. CytoDyn is known for specializing in...
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...
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