FDA Clears Test for Detecting HIV Drug-Resistant Mutations
The test may help clinicians tailor HIV therapy for their patients.
All articles by Steve Duffy
Baloxavir Marboxil Approved for Patients at High Risk of Flu-Related Complications
The FDA has approved a supplemental NDA for Xofluza for the treatment of acute, uncomplicated influenza in patients aged 12 years and older.
Emtricitabine and Tenofovir Alafenamide Combination for HIV-1 PrEP Gets FDA Approval
The FDA has approved Descovy for HIV-1 PrEP in at-risk adults and adolescents (≥35kg) to reduce the risk of sexually acquired HIV-1 infection, excluding individuals at-risk from receptive vaginal sex.
Novel Antifungal Gains Fast Track Designation for Seven Indications
The FDA has granted Fast Track designations to both the oral and intravenous formulations of fosmanogepix for 7 antifungal indications.
Investigational Zika Vaccine Gets Fast Track Status
An investigational mRNA vaccine to prevent Zika virus infection has been granted Fast Track designation by the FDA.
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