Rethymic Approved for Pediatric Congenital Athymia
The Food and Drug Administration has approved the Biologics License Application for Rethymic® (allogeneic processed thymus tissue-agdc), a one-time regenerative…
USPSTF: Starting Aspirin in Patients 60 or Older for Primary CVD Prevention Not Recommended
The US Preventive Services Task Force (USPSTF) has released an updated draft recommendation statement on the use of aspirin to…
Dialysis Facilities Persevered Through Hurricane Ida
Dialysis facilities in Louisiana again had to swing into emergency mode to ensure continuity of patient care during a major…
Ciclesonide May Be Promising Outpatient Therapy for Early COVID-19
In patients with mild to moderate COVID-19, ciclesonide inhaler treatment eradicates SARS-CoV-2 earlier and prevents progression to COVID-19. These were…
FDA Panel Votes on Maribavir for Post-Transplant CMV Infection
The Food and Drug Administration (FDA)’s Antimicrobial Drugs Advisory Committee voted unanimously to recommend the use of maribavir for the…
Tavneos Approved for ANCA-Associated Vasculitis
The Food and Drug Administration has approved Tavneos (avacopan) as an adjunctive treatment for adults with severe active anti-neutrophil cytoplasmic…
Gantenerumab Designated Breakthrough Therapy for Alzheimer Disease
The Food and Drug Administration has granted Breakthrough Therapy designation to gantenerumab for the treatment of Alzheimer disease. Gantenerumab is…
Cholesterol-Lowering Medications, Diuretics May Elevate Risk of Geographic Atrophy Progression
Perimeter-adjusted geographic atrophy (GA) progression rate could be linked to the presence of GA in the fellow eye and systemic…
Novel Sodium Phenylbutyrate Formulation Under Review for Urea Cycle Disorders
The Food and Drug Administration (FDA) has accepted for filing the New Drug Application for ACER-001 (sodium phenylbutyrate) for the…
Posoleucel Gets Orphan Drug Status for Virus-Associated Hemorrhagic Cystitis
The Food and Drug Administration (FDA) has granted Orphan Drug designation to posoleucel (Viralym-M, ALVR105) for the treatment of virus-associated…