国家药监局关于修订人纤维蛋白原说明书的公告（2025年第101号） 发布日期 2025-10-14 根据药品不良反应评估结果，为进一步保障公众用药安全，国家药监局决定对人纤维蛋白原说明书内容进行统一修订。现将有关事项公告如下： 一、所有上述药品的上市许可持有人均应当依据《药品注册管理办法》等有关规定，按要求修订说明书（见附件），于2026年1月10日前报省级药品监督管理部门备案。 修订内容涉及药品标签的，应当一并进行修订；说明书及标签其他内容应当与原批准内容一致。在备案之日起生产的药品，不得继续使用原药品说明书。药品上市许可持有人应当在备案后9个月内对已出厂的药品说明书及标签予以更换，或者以其他适当形式将更新信息告知患者。 二、 药品上市许可持有人应当对新增不良反应发生机制开展深入研究，采取有效措施做好药品使用和安全性问题的宣传培训，指导医师、药师或者患者合理用药。 三、 临床医师、药师应当仔细阅读上述药品说明书的修订内容，在选择用药时，应当根据新修订说明书进行充分的获益/风险分析。 四、 患者用药前应当仔细阅读药品说明书，使用

Oct. 13, 2025 -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today announced that complete data from the Phase 2b trial of rosnilimab, a pathogenic T cell depleter, in rheumatoid arthritis (RA), was accepted for a late-breaking oral presentation at American College of Rheumatology (ACR) Convergence 2025 in Chicago, IL, Oct. 24 – 29, 2025. “We are honored to be selected by ACR to present our late-breaking Pha

Oral presentation by Dr Zan highlighted novel Phase 1/2 SANTANA-225 study design of 225Ac-SSO110 in patients with ES-SCLC or MCC 225Ac-SSO110 achieves superior pharmacokinetics with minimal re-distribution of Actinium-225 daughter isotopes and 100% survival in preclinical studies Initial safety data from SANTANA-225 expected in 2026 Oct. 09, 2025 -- Ariceum Therapeutics (Ariceum), a targeted radiotherapeutics company dedicated to setting new standards in cancer care, today highlighted two or

Oct. 09, 2025 -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced the successful completion of the analytical validation of a cheek swab collection method for testing patients for both clinical trial usage as well as future commercial application. This major step marks a key milestone in advancing AD04 toward Food &

Nearly all participants (11 of 12) experienced clinically meaningful hearing improvements, including three who achieved normal hearing; eight with longer follow-up showed stability or continued improvement in their hearing Among three who completed speech assessments, all showed significant improvement with one able to identify one- and two-syllable words with no visual cues and respond to distant sounds and speech in noisy environments Latest DB-OTO data presented at AAO-HNSF; U.S. regulatory s

Company engaged patients diagnosed with chronic babesiosis via social media in a nationwide naming competition A $5K donation from the Company was split between ILADEF and GLA to recognize the winning name B-FREE, a Phase 2 trial, will commence in early November and run for approximately 12 months Oct. 09, 2025 -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees Pharma” or the “Company”), a pharmaceutical company focused on developing new medicines for vector-borne disease,

13 October 2025 Delivers on all four of President Trump's requests reducing cost of medicines Preserves America's role as a global powerhouse in biopharmaceuticals innovation AstraZeneca to invest $50bn in manufacturing and R&D to support domestic sourcing AstraZeneca today announces a historic agreement with President Donald J. Trump's administration to lower the cost of prescription medicines for American patients while preserving America's cutting-edge biopharmaceutical innovation. At a lan

Oct. 09, 2025 -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced new results that demonstrate buntanetap’s ability to attenuate inflammation and improve cellular health in Alzheimer’s patients, suggesting potential disease-modifying effects beyond symptomatic relief. The analysis of patient sam

Preclinical data demonstrates that Shape’s engineered AAV5 variant, SHP-DB1, efficiently targets the NHP brain after intravenous injection and transduces >95% of neurons in the Parkinson's Disease-critical substantia nigra Shape’s novel RNAfix® gene therapy enables targeted knockdown of alpha-synuclein in mouse and NHP brain, supporting the therapeutic development of a first-in-class disease-modifying treatment for Parkinson's Disease Oct. 10, 2025 -- Shape Therapeutics, a leader in RNA-bas

Shareholders to Receive $54 Per Share in Cash and CVR of $6 Per Share Advances Akero’s Mission of Bringing Novel Therapies to Patients with High Unmet Medical Needs Oct. 09, 2025 -- Akero Therapeutics, Inc. (“Akero”) (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced that it has entered into a definitive agreement to be acquired by Novo Nordisk A/S (“Novo Nordisk”) for