FDA监管行动 - 2025年9月FDA向从事GLP-1类药物司美格鲁肽与替尔泊肽配制或制造的企业发出50余封警告信，大部分发布于9月9日 [4] - 警告信主要针对企业网站与宣传材料中被认定为虚假或具有误导性的表述，例如宣称配制制剂是“仿制版本”或含有“相同活性成分” [4] - FDA强调其不对配制药品的安全性、有效性或质量进行评估，且这类药品与FDA已批准的版本并不相同 [4] 警告信具体内容与要求 - FDA就企业声称其产品在减重方面“安全有效”的表述发出警告，包括宣称能够带来“真实效果”或“经证实的有效性” [6] - 警告信不仅寄往配制药企业，持有FDA批准的品牌原研企业也因一档黄金时段电视专题节目收到警告，FDA认为该节目“对其产品安全性造成了误导性印象” [6] - 收到警告信的公司需在15个工作日内作出回应，提交纠正行动计划或合理说明，未能解决违规问题可能面临产品扣押或禁令等执法行动 [6] 行业背景与影响 - FDA的行动发生在GLP-1疗法用于肥胖与2型糖尿病治疗需求飙升，配制药企业介入满足需求之际 [6] - 警告意味着从事GLP-1药品配制的公司需要重新评估标签、广告与推广策略 [6] - FDA信件表明任何暗示与已批准药品等效的表述——无论是直接还是隐含——都可能受到执法 [6]

股票表现与前景 - 自上次分析以来 礼来公司股价已上涨9% [1] - 预计更广泛的医疗保健行业势头将在2026年增强 [1] - 当前仍被视为一个理想的入场点 [1] 分析师持仓披露 - 分析师通过股票所有权、期权或其他衍生品对礼来公司持有有益的多头头寸 [2]

Down-to-the wire team negotiations capped a long dance between President Trump and CEO Albert Bourla. ...

Accessibility StatementSkip Navigation Combination reduced the risk of disease progression or death by 46% and risk of death by 27% in pivotal Phase 3 IMforte trial Zepzelca and atezolizumab combination added to National Comprehensive Cancer Network® Guidelines for SCLC For U.S. media and investors only DUBLIN, Oct. 2, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) has granted approval for Zepzelca® (lurbinectedin) in combination ...

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) in combination with lurbinectedin (Zepzelca®) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy wit. ...

PresentationDirk ThyeCEO, Chief Medical Officer & Director Greetings, everyone, and welcome to our first ever Investor Day for Quince Therapeutics. My name is Dirk Thye, and I'll be walking you through the beginning elements of our presentation. We've got a full agenda for you today. I'm going to start by giving you an overview of Quince Therapeutics, our technology, our development plans and our key investment highlights. And then I'm going to hand it over to a series of departmental and technical experts ...

In the current session, Bristol-Myers Squibb Inc. (NYSE:BMY) is trading at $45.73, after a 3.58% decrease. Over the past month, the stock decreased by 2.06%, and in the past year, by 15.25%. With performance like this, long-term shareholders are more likely to start looking into the company's price-to-earnings ratio. How Does Bristol-Myers Squibb P/E Compare to Other Companies?The P/E ratio is used by long-term shareholders to assess the company's market performance against aggregate market data, historical ...

SEATTLE and VANCOUVER, British Columbia, Oct. 02, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline for treatment of nicotine dependence for smoking cessation, today announced that effective October 1, 2025, Achieve’s board of directors approved stock option grants to purchase an aggregate of 161,000 shares of its common stock for five new employees under Achieve’s 2024 E ...

The U.S. Food and Drug Administration on Thursday has expanded the approval for Jazz Pharmaceuticals' therapy as a maintenance treatment of adult patients with a type of lung cancer. ...

Alnylam Pharmaceuticals (NASDAQ:ALNY) has pulled a television ad for its drug Amvuttra (vutrisiran) after the U.S. FDA determined the spot was misleading. Amvuttra is approved for two heart conditions, hereditary transthyretin-mediated amyloidosis (ATTR-CM) and polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN). ...