The U.S. Food and Drug Administration approved the expanded use of Alexion Pharmaceuticals Inc.’s Ultomiris (ravulizumab-cwvz) to include children (1 month of age and older) and adolescents with paroxysmal nocturnal hemoglobinuria (PNH).
The U.S. Food and Drug Administration greenlit AstraZeneca’s Farxiga (dapagliflozin) under priority review for the treatment of chronic kidney disease in patients at risk of progression with or without type 2 diabetes.
Regeneron and Sanofi’s checkpoint inhibitor Libtayo (cemiplimab-rwlc) won U.S. Food and Drug Administration approval for the first-line treatment of patients with advanced non-small cell lung cancer whose tumors have high PD-L1 expression.
The U.S. FDA approved Merck & Co. Inc.’s Keytruda for a hard-to-treat form of bladder cancer, making the blockbuster therapy the first new treatment for the cancer in more than two decades.
The U.S. Food and Drug Administration approved expanded use of Regeneron Pharmaceuticals Inc. and Sanofi SA’s eczema drug Dupixent to include patients aged between 12 and 17 years.
FDA approved Imbruvica combined with Gazyva for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma.
Sanofi SA’s eczema drug Dupixent was approved by the U.S. Food and Drug Administration as an additional maintenance therapy in patients with two types of asthma.
The Janssen Pharmaceutical Companies of J&J announced the U.S. FDA approval of Imbruvica (ibrutinib) in combination with rituximab for the treatment of Waldenström’s macroglobulinemia.
Days after rejecting Regeneron’s attempt to secure a supplemental approval for Eylea, the FDA approved a new dosing label for the drug in wet age-related macular degeneration (wet AMD).
The Food and Drug Administration approved Bristol-Myers Squibb’s Opdivo for patients whose lung cancer had progressed even after undergoing chemotherapy and at least one other therapy.