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...
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...
Venezuela is the third largest medical device market in Latin America, following Brazil and Mexico, which makes understanding Venezuela’s medical device regulatory pathway crucial for MedTech companies expanding into Latin America (LATAM). Somewhat similar...
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...
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...
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...
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