FDA Updates Articles
The U.S. Food and Drug Administration has granted full approval to Travere Therapeutics’ Filspari (sparsentan) to slow kidney function decline in adults with primary IgA nephropathy.
The U.S. Food and Drug Administration has granted breakthrough device designation to Revita System (Fractyl Health Inc.) for the maintenance of weight loss after discontinuation of glucagon-like peptide-1 medications.
The U.S. Food and Drug Administration has approved a blood test to screen for colorectal cancer in individuals aged 45 and older with an “average risk” of colon cancer.
Sun Pharma’s LEQSELVI (deuruxolitinib) has been approved by the U.S. Food and Drug Administration to treat severe alopecia areata in adults.
Samsung Bioepis’ biologics license application for Epysqli (eculizumab-aagh) as a biosimilar to Soliris (eculizumab) has been approved by the U.S. Food and Drug Administration (FDA) to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis and atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.
The U.S. Food and Drug Administration has amended the emergency use authorizations of the. Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals.
The U.S. Food and Drug Administration has approved Sotyktu (deucravacitinib), a once-daily oral pill by Bristol Myers Squibb, for adults who have plaque psoriasis (a chronic, systemic, immune-mediated disease) severe enough to make them candidates for systemic therapy and phototherapy.
The U.S. Food and Drug Administration has approved Samsung Bioepis; Halima (adalimumab-bwwd) for the treatment of several autoimmune disorders, including rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn's disease.
AbbVie’s Rinvoq and Pfizer’s Cibinqo have been approved by the U.S. Food and Drug Administration (FDA) to treat moderate-to-severe atopic dermatitis.
The U.S. Food and Drug Administration (FDA) has approved Vyvgart (efgartigi-mod) to treat generalized myasthenia gravis (gMG) in adults who test positive for the anti-acetylcholine receptor (AChR) antibody.
The U.S. Food and Drug Administration (FDA) has approved Chemo- Centryx Inc.’s Avacopan, sold under the brand name Tavneos, to treat antineutrophil cytoplasmic antibody-associated vasculitides.
The U.S. Food and Drug Administration (FDA) issued a final rule to require new health warnings on cigarette packages and in cigarette advertisements, which feature textual statements with photo-realistic color images depicting some of the lesser-known, but serious health risks of cigarette smoking, including impact to fetal growth, cardiac disease, diabetes and more.
