The U.S. Food and Drug Administration recently published a report highlighting the benefits and risks of emerging augmented and virtual reality (AR/VR) medical devices. While these tools offer advancements in medical care delivery, the FDA emphasized several potential risks.
FDA has given Orphan Drug Designation to Faron Pharmaceuticals' bexmarilimab, a treatment designed for acute myeloid leukaemia. This breakthrough in drug designation is set to bring advantages in clinical development and commercialisation,
AbbVie has applied to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval for a new indication of risankizumab (Skyrizi) for treating moderately to severely active ulcerative colitis.
The U.S. Food and Drug Administration (FDA) has enhanced the approval parameters for Bristol Myers Squibb's Reblozyl, paving the way for its broader application in treating myelodysplastic syndromes (MDS).
The Food and Drug Administration (FDA) has given the green light to Novartis for its drug Tyruko, a biosimilar of Biogen’s blockbuster Tysabri, paving the way for more competitive pricing in the US market.
The FDA has granted approval to Roctavian, the first-ever gene therapy for severe Hemophilia A. Developed by BioMarin, this revolutionary treatment seeks to replace a faulty gene that inhibits Factor VIII production, a vital blood-clotting protein.
FDA has greenlit the first gene therapy, Elevidys, designed for pediatric patients with Duchenne muscular dystrophy (DMD) - a condition caused by a defective gene that leads to muscle weakness and atrophy.
Startup's success, the US Food and Drug Administration (FDA) has granted approval to CellTrans's Lantidra, marking the first-ever cell therapy to treat patients with type 1 diabetes.