The FDA has approved Rukobia (fostemsavir; ViiV Healthcare), in combination with other antiretrovirals, for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.
Hand sanitizers containing methanol, or wood alcohol, present a danger to individuals as the substance can be toxic when absorbed through the skin or life-threatening if ingested.
Descovy reached intracellular drug concentration levels above the estimated protective threshold significantly faster than Truvada.
In 2012, the FDA established the Truvada REMS for PrEP which required manufacturers to provide training materials, now that is no longer needed.
According to results from the MINISTONE-2 trial, baloxavir marboxil (Xofluza) was found to be safe and effective in children 1 to less than 12 years old with an influenza infection.
The Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices (ACIP) has voted to recommend that pediatric patients (2 to 18 years old) who have not previously received hepatitis A vaccine be routinely vaccinated at any age. Currently, the CDC recommends routine hepatitis A vaccination for children 12 to 23 months of…
The pediatric approval was based on data from an open label, single arm trial that evaluated the efficacy, safety, and pharmacokinetics of Biktarvy in virologically suppressed children (6 to <12 years old; n=50) and adolescents (12 to <18 years old; n=50).
The FDA’s Antimicrobial Drugs Advisory Committee voted in favor of pretomanid, as part of a combination regimen with bedaquiline and linezolid, for the treatment of pulmonary extensively drug resistant, treatment intolerant, or nonresponsive multidrug resistant tuberculosis.
The CDC announced an expected 3 to 10 month shortage of Aplisol (tuberculin purified protein derivative [PPD], diluted), used as an aid in the diagnosis of tuberculosis.
The NDA for Talicia for the treatment of Helicobacter pylori (H. pylori) infection has been submitted to the FDA by RedHill Biopharma.
