AstraZeneca’s Fasenra (benralizumab) hit a roadblock in attempting to expand the medicine’s indications when the U.S. Food and Drug Administration issued a Complete Response Letter for chronic rhinosinusitis with nasal polyps (CRSwNP).
Pfizer’s candidate treatment for patients diagnosed with active ankylosing spondylitis (AS) was approved by the U.S. Food and Drug Administration under a supplemental New Drug Application.
The U.S. Food and Drug Administration approved Merck’s anti-PD-1 therapy Keytruda for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB or IIC melanoma following complete resection. Additionally, the FDA expanded the indication for Keytruda as adjuvant treatment for stage III melanoma following complete resection to include pediatric patients (12 years and older).
Janssen Pharmaceutical and Amgen received another regulatory win for Darzalex Faspro (daratumumab and hyaluronidase-fihj) as the U.S. Food and Drug Administration approved the drug in combination with Amgen’s Kyprolis (carfilzomib) and dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.
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.
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.
