SPOTLIGHT -
FDA Grants QIDP & Fast Track Designations for SCY-078 to Treat Vulvovaginal Candidiasis
The FDA has granted QIDP and Fast Track Designations for the oral formulation of SCY-078 for the treatment of vulvovaginal candidiasis.
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FDA Accepts NDA for SUBA-Itraconazole Capsules for Treatment of Systemic Fungal Infections
The FDA has accepted for review the NDA for Mayne Pharma’s SUBA-Itraconazole capsules for the treatment of 3 systemic fungal infections.
Supplemental Biologics License Application for .5 mL Influenza Vaccine in Children 6-35 Months Accepted by FDA
If this indication is approved, physicians will be able to reserve the vaccine for young children to protect them against the 2019-2020 flu season.
Grindr Found to Be Sharing Users' HIV Status With Other Companies
On the heels of revealing a new feature promoting HIV testing, a data analysis finds that the app was sharing sensitive information with other companies.
Improving Access to Patient Care & Time to Viral Suppression Using HIV Rapid Entry Programs
Implementation of a rapid entry program decreased time to first provider appointment, time to initiation of ART, and time to viral suppression in the Southern United States.
Risk of Female HIV Acquisition Per Sex Act Increases During Pregnancy
Recent research presented at CROI 2018 finds that the risk of female HIV acquisition per sex act steadily increased through pregnancy and was highest during postpartum.
Prioritizing HIV Transmission Clusters for Public Health Intervention May Reduce Future Infections
Researchers discuss a new method to rapidly detect HIV time-space clusters for public health intervention at CROI 2018.
Addressing Mental Health Imperative to Ending the HIV Epidemic
Mental health is a critical component of ending the HIV epidemic.
WHO Launches New Guidance On Cryptococcal Meningitis
At CROI 2018, the World Health Organization released updated guidelines for cryptococcal disease in HIV-infected adults.
Cannabis Use May Reduce HIV-Associated Inflammation & Immune Activation In ART-Treated Patients
A recent study finds a potential link between cannabis use and possible beneficial reduction in systemic inflammation and immune activation in ART-treated HIV patients.
FDA Approves Vancomycin Hydrochloride for Treatment of CDAD & Staphylococcus aureus Enterocolitis
The FDA has approved Firvanq for the treatment of C. diff-associated diarrhea and enterocolitis caused by Staphylococcus aureus.
FDA Approves Expanded Indication for Quadrivalent Influenza Vaccine
GlaxoSmithKline has announced that the FDA's Center for Biologics Evaluation and Research has approved expanding the indication for their influenza vaccine to include use in those 6 months of age and older.
FDA Approves Juluca, First Two-Drug HIV Regimen
The FDA has just approved the first two-drug regimen for treating certain individuals living with HIV.
James McKinnell, MD: Outcomes of Delafloxacin Treatment for Skin Structure Infections
Why is delafloxacin unique compared to other fluoroquinolones? Find out more.
Narrow-Spectrum Antibiotic for C. Difficile Fails to Show Treatment Benefit Over Vancomycin
Surotomycin fails to show benefit over vancomycin for the treatment of Clostridium difficile infection in a phase 3 trial.
Development of IPM's Vaginal Ring Designed to Reduce HIV-1 Receives $25 Million Boost
Made of a flexible silicone material, the ring contains dapivirine, a non-nucleoside reverse transcriptase inhibitor that blocks HIV’s ability to replicate inside of a healthy cell.
Solosec Approved for Treatment of Bacterial Vaginosis
Bacterial vaginosis is the most common gynecologic infection in the United States, affecting 21 million women between the ages of 14 and 49, each year.
