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Q How do you find FDA approvals? A A Catalysts Calendar is one way of tracking all the decisions in a single place. Usually, the FDA puts out a release and/or communicates to the company, which in turn will issue a press release. Create a Watchlist FREE: Follow your stocks and crypto...
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...
2024年7月,FDA发布《Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2024》,对涉及生物制品的技术指南发布计划,进行具体规定。 1.1-技术指南计划整体情况 下面表格介绍了CBER针对各个技术专题发布指南的数量。 1.2-重点指南介绍 ...
FDA approval of ORLYNVAH (oral sulopenem) for the treatment of uncomplicated urinary tract infections. News release. Iterum Therapeutics. October 25, 2024. Accessed October 25, 2024. https://www.iterumtx.com/news/press-releases/detail/136/iterum-therapeutics-receives-u-s-fda-approval-of ...
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...
"We are targeting a commercial launch in the first half of calendar year 2025, and given our recent experience in Canada we are very optimistic about the potential of GRAFAPEX™ in the US market," added Richard Labelle, Medexus's Chief Operating Officer. "We an...
6. June 17, 2022, Meeting of the Psychopharmacologic Drugs Advisory Committee Meeting Announcement. FDA website. June 17, 2022. Accessed July 1, 2022. https://www.fda.gov/advisory-committees/advisory-committee-calendar/june-17-2022-meeting-psychopharmacologic-drugs-advisory-committee-meeting-annou...
2024. Krystal finished the third quarter of last year with 284 start forms for the treatment; it expects an 85% conversion rate to prescriptions. The drug brought in third-quarter sales of $8.6 million. Next up is a potential European approval, which the company is anticipating ...