Medicines Articles
The U.S. Food and Drug Administration (FDA) has approved nirsevimab to protect newborns from respiratory syncytial virus (RSV).
The U.S. Food and Drug Administration has approved Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression (PPD) in adults.
The U.S. Food and Drug Administration has approved the birth control pill Opill (norgestrel), manufactured by Perrigo, to be available over-the-counter — the first nonprescription birth control pill in the United States.
Pfizer's ABRYSVO, a respiratory syncytial virus (RSV) vaccine, has been approved by the U.S. Food and Drug Administration for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth up to 6 months of age by active immunization of pregnant women at 32 through 36 weeks gestational age.
The U.S. Food and Drug Administration (FDA) has converted Leqembi (lecanemab-irmb), indicated to treat adult patients with Alzheimer’s disease, to traditional approval following a determination that a confirmatory trial verified clinical benefit.
The U.S. Food and Drug Administration has approved LITFULO (ritlecitinib), a once-daily oral treatment, for individuals 12 years of age and older with severe alopecia areata.
The subcutaneous formulation of argenx’s Vyvgart has been approved by the U.S. Food and Drug Administration to treat generalized myasthenia gravis.
The U.S. Food and Drug Administration has approved Roche’s Columvi, an antibody-based therapy chemically known as glofitamab.
The US Food and Drug Administration has granted fast track designation for Kyverna Therapeutics’ KYV-101 to treat refractory lupus nephritis.
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.
Dutch investigators conducted a systematic review and meta-analysis of studies on the effectiveness of IVIG treatment of this specific population.