Peginterferon Lambda Gets Breakthrough Tx Status for Hepatitis D
The FDA has granted Breakthrough Therapy designation to peginterferon lambda (Lambda; Eiger BioPharmaceuticals) for the treatment of hepatitis delta virus (HDV) infection.
Infectious Disease
Investigational Zika Vaccine Gets Fast Track Status
An investigational messenger RNA (mRNA) vaccine to prevent Zika virus infection has been granted Fast Track designation by the Food and Drug Administration.
FDA Approves First-In-Class Antibiotic to Treat Community-Acquired Bacterial Pneumonia
The FDA has approved Xenleta (lefamulin; Nabriva Therapeutics) for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.
Recommendations Developed for Management of Lyme Disease
Public comment period for these guidelines has been extended 30 days to Sept. 9, 2019
ACIP Recommends Catch-Up HPV Vaccines Through Age 26
For adults aged 27 to 45 years, vaccination may be beneficial for some who are inadequately vaccinated
Pretomanid Approved as Part of a New Regimen for Highly Drug-Resistant Tuberculosis
The FDA has approved pretomanid tablets (TB Alliance) in combination with bedaquiline and linezolid for the treatment of adults with pulmonary extensively drug resistant (XDR), treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB).
FDA Warns of “Cure-All” Products That Actually Contain Bleach
The FDA is warning consumers to stop using products known as Miracle or Master Mineral Solution, Miracle Mineral Supplement, MMS, Chlorine Dioxide Protocol, and Water Purification Solution due to numerous reports of significant health issues.
Sirturo Approved to Treat Adolescent Patients With Pulmonary Multidrug-Resistant TB
The FDA has approved Sirturo (bedaquiline; Janssen) for use in pediatric patients aged 12 to less than 18 years and weighing at least 30kg as part of combination therapy for pulmonary multidrug-resistant tuberculosis (MDR-TB), when an effective treatment regimen cannot otherwise be provided.
FDA Clears Rapid, Point-of-Care Test to Detect Chlamydia, Gonorrhea
The FDA has granted 510(k) clearance to binx io (binx health) for women’s health, a molecular point-of-care diagnostic testing platform for detecting chlamydia and gonorrhea in approximately 30 minutes.
FDA Panel Votes on New HIV Pre-Exposure Prophylaxis Treatment
Currently, study data to directly support Descovy use for PrEP in cisgender women or adolescents is lacking.
