UCB’s Fintepla (fenfluramine) oral solution CIV was approved in the United States for the treatment of seizures associated with Lennox-Gastaut syndrome in patients two years of age and older. Additionally, the FDA granted pediatric exclusivity for the product.
Novartis’ proposed drug for adults diagnosed with a certain type of advanced prostate cancer was given the green light for commercialization.
Bristol Myers Squibb’s Opdualag – a new, first-in-class, fixed-dose combination of nivolumab and relatlimab, administered as a single intravenous infusion – was approved by the U.S. Food and Drug Administration for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.
AstraZeneca and Merck & Co. Inc. announced Lynparza (olaparib) was approved in the United States for the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery.
Biosimilar development continues to advance for the U.S. market in anticipation of becoming an alternative to a brand drug with similar safety and efficacy.
The U.S. Food and Drug Administration approved the expanded use of Bristol Myers Squibb’s cancer drug Opdivo along with chemotherapy as treatment that patients with an aggressive form of lung cancer receive before surgery.
The U.S. health regulator approved a therapy developed by Johnson & Johnson and the healthcare company’s China-focused partner Legend Biotech Corp. to treat a type of white blood cell cancer.
The U.S. Food and Drug Administration approved CTI BioPharma Corp.’s drug for treating adult patients with a type of bone marrow cancer who also have low blood platelet count.
The U.S. Food and Drug Administration approved the use of Purdue Pharma’s candidate injectable treatment for partially or completely reversing opioid drug effects.
The U.S. health regulator approved Eli Lilly and partner Boehringer Ingelheim’s drug, Jardiance, for expanded use in reducing the risk of death and hospitalization for all patients with heart failure.