FDA Updates Articles
The U.S. Food and Drug Administration has approved Amgen’s Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for the treatment of several autoimmune conditions.
The U.S. Food and Drug Administration has approved Gilead Sciences’ Vemlidy (tenofovir alafenamide,TAF) 25 mg once-daily treatment for adults with chronic hepatitis B virus(HBV) infection with compensated liver disease.
A lung cancer vaccine developed in Cuba has been approved by the U.S. Food and Drug Administration for a clinical trial at Roswell Park Cancer Institute in Buffalo, N.Y.
The U.S. Food and Drug Administration granted orphan drug designation to dusquetide (SGX942, Soligenix) for the treatment of macrophage activation syndrome.
The U.S. Food and Drug Administration approved cabozantinib (Cabometyx, Exelixis) to treat advanced renal cell carcinoma (RCC) in patients who have received prior anti-angiogenic therapy.
True North Therapeutics’ TNT009 for the treatment of autoimmune hemolytic anemia, including cold agglutinin disease (CAD), has been granted orphan drug status by the U.S. Food and Drug Administration.
Empliciti (elotuzumab) in combination with Revlimid (lenalidomide) and dexamethasone (a type of corticosteroid) has been approved by the U.S. Food and Drug Administration to treat individuals with multiple myeloma who have received one to three prior medications.
The U.S. Food and Drug Administration has approved Celltrion’s Inflectra (infliximab-dyyb), a biosimilar version of Johnson & Johnson’s Remicade drug used to treat autoimmune diseases.
The U.S. Food and Drug Administration has approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with BRAFV600 wildtype and BRAFV600 mutation-positive unresectable or metastatic melanoma.
The U.S. Food and DrugAdministration approved Merck and Co.’s Bridion (sugammadex) injection to reverse the effects of neuromuscular blockade induced by rocuroniumbromide and vecuronium bromide.
The U.S. Food and Drug Administration granted accelerated approval for pembrolizumab (Keytruda, Merck & Co.) for treatment of patients with advanced (metastatic)
non-small cell lung cancer.