FDA News
Officials with the FDA have approved nivolumab (Opdivo; Bristol Myers Squibb) with ipilimumab (Yervoy; Bristol Myers Squibb) for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC). Read More ›
Nivolumab (Opdivo; Bristol Myers Squibb) with ipilimumab (Yervoy; Bristol Myers Squibb) is now FDA approved for patients aged ≥12 years with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair–deficient (dMMR) colorectal cancer (CRC). Read More ›
Officials with the FDA have approved tislelizumab-jsgr (Tevimbra; BeOne Medicines, Ltd, formerly known as BeiGene, Ltd), in combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express programmed death-ligand 1 (PD-L1) (≥1). Read More ›
Officials with the FDA have approved chenodiol (Ctexli; Mirum) for the treatment of cerebrotendinous xanthomatosis (CTX) in adults, making it the first FDA-approved therapy to address this rare lipid storage disease. Read More ›
The FDA has approved a hormone-free, copper intrauterine device (IUD; Miudella; Sebela Pharmaceuticals) for the prevention of pregnancy in people of reproductive potential for up to 3 years, making it the first hormone-free IUD to be FDA approved in more than 40 years, according to a press release. Read More ›
Officials with the FDA have approved the allergy immunotherapy tablet Odactra (ALK) for use in young children with house dust mite allergy-induced allergic rhinitis, with or without conjunctivitis, in children aged 5 through 11 years, in addition to patients aged 12 through 65 years. Read More ›
GSK’s meningococcal groups A, B, C, W, and Y vaccine (Penmenvy) has been approved by the FDA for use in individuals aged 10 through 25 years. Read More ›
The FDA has approved the twice-daily oral capsule iptacopan (Fabhalta; Novartis) for the treatment of adults with complement 3 glomerulopathy (C3G) to reduce proteinuria. Read More ›
Officials with the FDA have approved the first subcutaneous apomorphine infusion (Onapgo; Supernus) for patients with Parkinson’s disease (PD). Read More ›
The FDA has approved a rapid-acting human insulin biosimilar to Novolog (Novo Nordisk), insulin-aspart-szjj (Merilog; Sanofi-Aventis), for glycemic control in adults and pediatric patients with diabetes mellitus. Read More ›