The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to inebilizumab (Viela Bio), an investigational monotherapy for neuromyelitis optica spectrum disorder (NMOSD).
The FDA has granted Breakthrough Therapy designation to elafibranor for the treatment of primary biliary cholangitis (PBC) in adults with inadequate response to ursodeoxycholic acid (UDCA).
According to the results of a systematic review, there is a lack of evidence supporting the potential health benefits of kombucha, a fermented tea beverage, in humans.
ADMA Biologics announced that the FDA has approved Asceniv (immune globulin intravenous [human] – slra) 10% Liquid for the treatment of primary humoral immunodeficiency disease (PIDD) in patients aged ≥12 years.
Enzyvant announced that the Food and Drug Administration (FDA) has granted RVT-801 both Rare Pediatric Disease and Fast Track designations for Farber disease.
This slideshow reviews drug information for Firdapse. Click here for the complete Firdapse monograph.
Based on our finding, hydrochlorothiazide should be considered a possible offending agent when a patient presents with symptoms suspicious of drug induced lupus,” the study authors concluded.
Veloxis announced that the Food and Drug Administration (FDA) has approved Envarsus XR (tacrolimus extended-release) tablets to prevent organ rejection in de novo kidney transplant patients in combination with other immunosuppressants.
Data from a Phase 2 trial of baricitinib for the treatment of SLE supporting the Fast Track designation were published in The Lancet and presented at the European Congress of Rheumatology earlier this year.
The designation was granted to Revive Therapeutics, a company that specializes in cannabis-based pharmaceuticals.
