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 […]
The European Commission (EC) has granted Novartis approval for a significant update to the label of its psoriatic arthritis treatment, Cosentyx (secukinumab). This update introduces new dosing flexibility, allowing for administration of up to 300mg based on individual clinical response. This development provides clinicians with enhanced options to tailor treatments for their patients suffering from […]
Mylan has officially launched Hulio, its biosimilar to AbbVie’s Humira (adalimumab), across major European markets. This launch follows the European Commission’s recent approval of Hulio for all indications of the reference product. Hulio will be accessible to patients in Europe as soon as possible, thanks to a partnership between Mylan and Fujifilm Kyowa Kirin Biologics. […]
Merck has achieved a significant milestone by obtaining approval from the European Commission (EC) for its cancer immunotherapy, Keytruda (pembrolizumab), to be used in combination with Eli Lilly’s chemotherapy drug pemetrexed (ALIMTA) and platinum chemotherapy. This approval specifically targets the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC) in adults who do not […]
In a significant development for melanoma treatment, the European Commission (EC) has granted Novartis approval for its combination therapy of Tafinlar (dabrafenib) and Mekinist (trametinib). This approval is specifically for adjuvant therapy in stage III melanoma patients who are positive for the BRAF V600 mutation and have undergone complete surgical resection. The approval is based […]
The Janssen Pharmaceutical Companies of Johnson & Johnson have achieved a significant milestone with the European Commission’s approval of Darzalex (daratumumab) for use as an initial therapy in adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT). This approval allows for the combination of daratumumab with bortezomib, […]
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 […]
Amgen Inc., a leading American biopharmaceutical company, has achieved a significant milestone with the approval of its drug Parsabiv (etelcalcetide) by the European Commission (EC) for the treatment of secondary hyperparathyroidism (sHPT) in adult patients undergoing hemodialysis due to chronic renal disease. Breakthrough in sHPT Management sHPT is a complex and chronic condition that affects […]
