European Medicines Agency

(IN BRIEF) Roche’s Vabysmo® (faricimab) prefilled syringe has received European Medicines Agency approval for treating three major retinal conditions: neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema caused by retinal vein occlusion (RVO). Serving over nine … Read the full press release →

(IN BRIEF) AstraZeneca’s Tagrisso (osimertinib) has been recommended for approval in the EU for treating adult patients with unresectable, locally advanced non-small cell lung cancer (NSCLC) with EGFR mutations who have not experienced disease progression after platinum-based chemoradiation therapy. This … Read the full press release →

(IN BRIEF) The European Medicines Agency has approved Dupixent as the first treatment for eosinophilic esophagitis (EoE) in young children aged one to 11, marking a significant step in managing this condition in a critical developmental phase. The approval is … Read the full press release →

(IN BRIEF) AstraZeneca and Ionis’ drug Wainzua (eplontersen) has been recommended for approval in the European Union for treating hereditary transthyretin-mediated amyloidosis (ATTRv-PN) in adults with stage 1 or 2 polyneuropathy. Based on the positive results from the NEURO-TTRansform Phase … Read the full press release →

(IN BRIEF) Novo Nordisk’s Alhemo® (concizumab) has been recommended for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). If approved, Alhemo® will become the first once-daily subcutaneous prophylactic treatment for people aged 12 … Read the full press release →

(IN BRIEF) Roche has announced positive two-year data from its RAINBOWFISH study, showcasing the effectiveness of Evrysdi® (risdiplam) in treating children with spinal muscular atrophy (SMA) when administered before symptoms appear. The study revealed that most children achieved key motor … Read the full press release →

(IN BRIEF) Roche has announced positive results from its phase III REGENCY study, showing that its drug Gazyva®/Gazyvaro® (obinutuzumab) significantly outperformed standard therapy in treating active lupus nephritis. The study found that patients receiving Gazyva/Gazyvaro, in combination with standard therapies, … Read the full press release →

(IN BRIEF) Pfizer and BioNTech’s Omicron KP.2-adapted COVID-19 vaccine has received a positive recommendation from the European Medicines Agency’s (EMA) CHMP for use in individuals aged six months and older. Pending final approval from the European Commission, the vaccine will … Read the full press release →

(IN BRIEF) Eurojust will participate in the 47th annual World Port Days in Rotterdam from September 6-8, 2024. The event, which highlights the importance of European ports like Rotterdam, will feature Eurojust in the European Pavilion. This space, organized by … Read the full press release →

(IN BRIEF) AstraZeneca’s Truqap, in combination with Faslodex, has received a positive recommendation from the European Medicines Agency (EMA) for treating estrogen receptor-positive, HER2‑negative locally advanced or metastatic breast cancer with specific genetic alterations. The recommendation follows promising results from … Read the full press release →

(IN BRIEF) AstraZeneca and Sanofi celebrate the approval of Beyfortus (nirsevimab) in Japan by the Ministry of Health, Labour, and Welfare for preventing lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in neonates, infants, and children entering … Read the full press release →

(IN BRIEF) DPI, BII, and the EBRD have reached a binding agreement to fully exit their investment in KELIX bio, a pan-African biopharmaceutical platform, through its acquisition by Mubadala Investment Company. Founded in 2020, KELIX bio has rapidly grown to … Read the full press release →

(IN BRIEF) Novartis has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting marketing authorization for Fabhalta® (iptacopan) for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) who … Read the full press release →

(IN BRIEF) The European Medicines Agency (EMA) has validated two marketing authorisation applications (MAAs) for datopotamab deruxtecan (Dato-DXd), developed by AstraZeneca and Daiichi Sankyo, for the treatment of nonsquamous non-small cell lung cancer (NSCLC) and hormone receptor (HR)-positive, HER2-negative breast … Read the full press release →

(IN BRIEF) Voydeya (danicopan), a first-in-class oral Factor D inhibitor, has been recommended for marketing authorization in the European Union (EU) as an add-on to ravulizumab or eculizumab for adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who experience residual haemolytic … Read the full press release →

(IN BRIEF) Boehringer Ingelheim has reported compelling results from its Phase II trial of Survodutide, a novel glucagon/GLP-1 receptor dual agonist, indicating its potential to become a leading treatment for Metabolic Dysfunction-Associated Steatohepatitis (MASH). In the trial, up to 83.0% … Read the full press release →

(IN BRIEF) GSK has submitted a regulatory application to the European Medicines Agency (EMA) to expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine to adults aged 50-59 who are at increased risk for RSV disease. The … Read the full press release →

(IN BRIEF) The Japanese Ministry of Health, Labour and Welfare (MHLW) has granted approval for Voydeya (danicopan), a groundbreaking oral Factor D inhibitor, for the treatment of paroxysmal nocturnal haemoglobinuria (PNH). Voydeya is indicated in Japan for use in combination … Read the full press release →