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 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...
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...
Aiming to expand the use of Zolgensma, Novartis has announced the launch of a new phase three study following the FDA’s decision to remove restrictions and partial clinical trial hold. Novartis plans to evaluate the use of Zolgensma to treat patients (aged 2-18) for...
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