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为了指导企业规范控制铝元素,2024年,FDA将发布《Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations》。 ◆180天独占权的新看法 FDA为了保护仿制药公司的积极性,对于首仿药公司给...
December 17, 2024 · 2 min read · Tristan Manalac Duchenne Muscular Dystrophy Déjà Vu for PepGen as FDA Places Hold on DMD Drug The FDA has put a stop to U.S. initiation of PepGen’s Phase II trial for its Duchene muscular dystrophy treatment. The company faced the same hurdle for...
following this up with afull approvalin July while also being named as one ofTime’s best inventionsof the year. Eisai hopes the drug can reach megablockbuster territory and go some way to make up for the major flop that was Aduhlem. That drug, originally...
Accessed October 25, 2024. https://www.fda.gov/advisory-committees/advisory-committee-calendar/september-9-2024-meeting-antimicrobial-drugs-advisory-committee-meeting-announcement-09092024 Iterum Therapeutics Provides Update on FDA Advisory Committee Discussion of Oral Sulopenem for the Treatment of u...
细胞和基因治疗产品是这几年国际和美国国内研发热点,有很多问题需要厘清。FDA发布这份指南,将促进相关问题的认知深化。这份指南编制工作在2024年已经被列为工作计划之一,没有完成,这次仍然被列为2025年工作计划之中。 ※Post Approval Methods to Capture Safety an...
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved IMDELLTRA™ (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with...
FDA是Food and Drug Administration的简称,中文名称为美国食品药品监督管理局,是美国政府在健康与人类服务部(DHHS) 下属的公共卫生部(PHS)中设立的执行机构之一,负责全国药品、食品、生物制品、化妆品、兽药、医疗器械以及诊断用品的管理。 FDA主要分测试和注册两个内容,医疗器械、化妆品、食品、药品类产品需要进行FDA注...
s investigational treatment for excessive daytime sleepiness and cataplexy in adults with narcolepsy, FT218. A portion of the new drug application (NDA) for the once-nightly sodium oxybate formulation relating to the REMS patent was deemed inappropriate, and pushed the approval deadline to June ...