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FDA approved and implemented updated warning labels for all opioid prescriptions.
FDA approved Amtagvi, the first cellular therapy indicated for the treatment of adult patients with unresectable melanoma or metastatic melanoma that previously has been treated with other therapies.
FDA has approved Alvotech’s Simlandi (adalimumab-ryvk) as the third interchangeable Humira biosimilar.
The U.S. Department of Health and Human Services and the General Services Administration have announced new guidance recommending that all federal facilities across the nation include overdose reversal medications in their safety stations on site.
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 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.
A new systematic review and meta-analysis conducted by U.S. and Nepalese collaborators supports the use of IVIG with glucocorticoids compared to IVIG alone.