In a significant breakthrough for treating inherited vision loss, Pennsylvania-based Spark Therapeutics has received European Commission (EC) approval for its pioneering gene therapy, Luxturna (voretigene neparvovec). Targeted at both children and adults, Luxturna addresses vision impairment caused by a rare, inherited retinal dystrophy associated with biallelic RPE65 mutations. This long-awaited approval now extends the gene […]
In a significant advancement for biopharmaceuticals, Novartis’ division Sandoz has secured approval from the European Commission (EC) for Hyrimoz (adalimumab), a biosimilar to AbbVie’s Humira. This approval encompasses all indications of the reference drug, including treatment for rheumatoid arthritis, Crohn’s disease, plaque psoriasis, uveitis, and ulcerative colitis, marking a pivotal step in broadening access to […]
AstraZeneca has reached a crucial milestone as the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Imfinzi (durvalumab) for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC). This recommendation paves the way for a new treatment option for […]