2024年8月23日,美国食品药品监督管理局(FDA)宣布批准安进公司的VEGF抑制剂Pavblu(aflibercept-ayyh)作为再生元公司的EYLEA(aflibercept,阿柏西普)的第五种生物仿制药,用于治疗新生血管性(湿性)老年性黄斑变性(AMD)、视网膜静脉阻塞(RVO)后黄斑...
2024年8月23日,美国食品药品监督管理局(FDA)宣布批准安进公司的VEGF抑制剂Pavblu(aflibercept-ayyh)作为再生元公司的EYLEA(aflibercept,阿柏西普)的第五种生物仿制药,用于治疗新生血管性(湿性)老年性黄斑变性(AMD)、视网膜静脉阻塞(RVO)后黄斑水肿、糖尿病性黄斑水肿(DME)和糖尿病性视网膜病变(DR)患者。 此前,FDA...
美国食品药品监督管理局药物评价和研究中心抗微生物产品办公室主任Edward Cox,M.D., M.P.H说:“Eylea对成年湿性AMD是一个重要的治疗选择”“它是潜在失明疾病和新治疗选择的可供利用是重要的。” 处方资料译自:http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125387lbl.pdf 处方资料重点 这些重点...
Meanwhile, Regeneron is working on expanding Eylea's label into additional indications. The FDA recently approved a 12-week dosing interval of Eylea injection in patients with wet AMD based on physician's assessment. Consequently, Eylea is now the only anti-VEGF drug for the treatment of wet AM...
Tarrytown, N.Y.-based Regeneron received some unwelcome news. The U.S. Food and Drug Administration (FDA) rejected the company’s attempt to secure a supplemental approval for its blockbuster drug Eylea as a once-per 12-week treatment for wet age-related
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An application for expanding the drug’s label for the indication of chronic spontaneous urticaria is under review in the United States with a target action date of April 18, 2025. The sBLA seeking label expansion of the drug for bullous pemphigoid was submitted in the fourth quarter of 2024....
Tristan Manalac Podcasts Tariff Threat Continues, More Meetings Cancelled, AbbVie Makes Obesity Play, More March 5, 2025 · 1 min read · Heather McKenzie Cancer BeiGene Gets Yet Another Label Expansion for PD-1 Drug Tevimbra Ma...
Blockbuster Vabysmo has already been available in Europe for the same three diseases in 6.0mg Vabysmo vials. The drug received its most recent approval in July this year when RVO was added to its EU label. Both the prefilled syringe and vials deliver faricimab, a bispecif...
Eylea, Eylea HD, and Avastin may all be used to treat neovascular (wet) age-related macular degeneration (AMD), as injections into the eye (intravitreal injections). Both Eylea and Eylea HD are FDA-approved for this indication, but use of Avastin is off-label (not an FDA-approved indicati...