Influenza Vaccine for Older Adults Granted Fast Track Status
The Food and Drug Administration has granted Fast Track designation to NanoFlu (Novavax) for seasonal influenza vaccination in adults ≥65 years.
All articles by Steve Duffy
Haymarket Medical Education Receives Interprofessional Joint Accreditation for the Healthcare Team
Caroline O. Pardo, Ph.D., General Manager for Haymarket Medical Education, is pleased to announce that HME, based in Paramus, NJ, has been accredited as a provider of interprofessional continuing education by the Accreditation Council for Continuing Medical Education, the Accreditation Council for Pharmacy Education, and the American Nursing Credentialing Center.
Renal Impairment Labeling Updates for Sofosbuvir-Based HCV Therapies
The FDA has approved updated labeling for Epclusa, Harvoni and Vosevi to include updated information regarding treatment of patients with HCV who have severe renal impairment including those with end stage renal disease who are on dialysis.
FDA Clears Test for Detecting HIV Drug-Resistant Mutations
The test may help clinicians tailor HIV therapy for their patients.
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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