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...
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...
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...
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...
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