Disease or Syndrome
Sandoz Wins Historic FDA Approval for First Two Interchangeable Denosumab Biosimilars Targeting Amgen’s Blockbuster Bone Therapy
Sandoz, FDA approval, Denosumab biosimilars, Wyost, Jubbonti, Interchangeable, Prolia, Xgeva, Amgen, Osteoporosis, Bone metastases, Cancer-related skeletal events, Patent litigation
Novo Nordisk’s Ozempic Shows Promising Kidney Benefits for Diabetic Patients
Ozempic, Novo Nordisk, Chronic kidney disease, Cardiovascular events, Expanded use, Semaglutide, FLOW trial, Reduced risk, Type 2 diabetes
“Regulating Hope Amidst Uncertainties: Novel ALS Treatments Face Complex Challenges”
ALS Treatments, Regulatory Uncertainty, Clinical Trials, Relyvrio, Masitinib, Antisense Therapy, Risk-Benefit Analysis, FDA Approval, Patient Advocacy
Sarepta’s ELEVIDYS Gaining Ground Amidst Anticipation for Expanded Label Approval
ELEVIDYS, Age, Muscular Dystrophy, Duchenne, Sarepta, Labels (device), Child
AstraZeneca Abandons Roxadustat’s US Future while Retaining Collaboration with FibroGen in China
FibroGen, roxadustat, China, Ultrasonography, AstraZeneca, Collaboration, chemotherapy-induced anemia, Retained
Interchangeable Humira Biosimilar Simlandi Joins Market Battle with Unique High-Concentration Formula
Simlandi, interchangeable, Biosimilars, Market
Venatorx Confident in Quick Resolution of Manufacturing Concerns for Cefepime-Taniborbactum Antibiotic Despite FDA Setback
United States Food and Drug Administration, Venatorx, CID, 2024-02-23, cefepime-taniborbactam, Manufacture
FDA Approves Allecra’s Exblifep, Giving Headstart Over Competition in Complicated Urinary Tract Infections
Urinary tract infection, Complicated
Improving Amylyx’s ALS Drug Relyvrio: Taste Masking and Withdrawal
Amylyx, ALS, Relyvrio, Taste Masking, Withdrawal, Patent Life