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FDA Approval: First Injectable PrEP for HIV

FDA Approval: First Injectable PrEP for HIV

Dec 21, 2021 | FDA, Health, News, Regulatory

The U.S. Food and Drug Administration (FDA) has given approval to start producing ViiV Healthcare’s cabotegavir, the first and only long-acting injectable pre-exposure prophylactic (PrEP) to reduce the risk of sexually acquired HIV-1. HIV-1 affects nearly 38 million...
CytoDyn HIV Justification Report: Guidance From FDA

CytoDyn HIV Justification Report: Guidance From FDA

Aug 13, 2021 | News, Regulatory

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 Grants Pre-Approval for IND for Potential HIV Cure

FDA Grants Pre-Approval for IND for Potential HIV Cure

Jun 14, 2021 | News, Regulatory

The U.S. Food and Drug Administration (FDA) has granted pre-approval for Enochian BioSciences’ Investigational New Drug (IND) application for a potential functional treatment or cure for HIV (human immunodeficiency disorder). The submission is based off of an...