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правобережный комитет по работе с населением липецк, Arvinas Announces FDA Acceptance of the New Drug Application for , FDA Accepts Arvinas, Pfizer's Vepdegestrant NDA for Breast Cancer Treatment, Arvinas and Pfizer's Vepdegestrant Significantly Improves Progression , Arvinas vepdegestrant NDA gains FDA acceptance - Pharmaceutical Technology, Arvinas and Pfizer Announce FDA Acceptance of NDA for Vepdegestrant , FDA Accepts Arvinas’s New Drug Application for Advanced Breast Cancer , Arvinas and Pfizer Report the US FDA’s NDA Submission of Vepdegestrant .
SymbolsSymbolsNews/Health Care/PFE/News DetailsFDA Accepts Arvinas, Pfizer's Vepdegestrant NDA for Breast Cancer TreatmentAinvestSaturday, Aug 9, 2025 7:41 am ET1min readArvinas and Pfizer announce the FDA's acceptance of the new drug application for vepdegestrant, a treatment for estrogen receptor-positive/human epidermal growth factor receptor 2-negative, ESR1-mutated advanced or metastatic breast cancer. The FDA has assigned a Prescription Drug User Fee Act action date of June 5, 2026.Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) have announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for vepdegestrant, a novel treatment for estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-), ESR1-mutated advanced or metastatic breast cancer. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of June 5, 2026 [1].Vepdegestrant, an investigational oral PROteolysis TArgeting Chimera (PROTAC) ER degrader, demonstrated statistically significant and clinically meaningful improvement in median progression-free survival versus fulvestrant in the pivotal Phase 3 VERITAC-2 clinical trial [1]. This trial, which enrolled 624 patients, showed that vepdegestrant could extend the time before the cancer progresses compared to the standard of care, fulvestrant [1].The acceptance of the NDA by the FDA marks a significant milestone in the development of vepdegestrant. The drug is being co-developed and co-commercialized by Arvinas and Pfizer, with both companies sharing the costs and potential profits [1]. The VERITAC-2 trial results were presented at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting and published in The New England Journal of Medicine [1].Vepdegestrant is the first PROTAC to demonstrate clinical benefit in patients with breast cancer, offering a potential best-in-class treatment option for patients in the second-line ESR1-mutant setting [1]. The FDA's Fast Track designation underscores the significant unmet need in this patient population and the potential for vepdegestrant to offer a meaningful new treatment option [1].The successful submission of the NDA and the upcoming PDUFA action date in June 2026 indicate a promising timeline for the approval of vepdegestrant. However, the approval process is subject to various risks and uncertainties, including the potential need for additional information or further studies by the FDA, as well as the ability to successfully commercialize the drug [1].Arvinas and Pfizer are committed to working with the FDA to ensure that vepdegestrant is approved and made available to patients as rapidly as possible. The companies' collaboration and shared development costs reflect their commitment to advancing innovative treatments for patients with advanced or metastatic breast cancer [1].References:[1] https://finance.yahoo.com/news/arvinas-announces-fda-acceptance-drug-200500022.htmlAInvest NewsletterDaily stocks & crypto headlines, free to your inboxGet Newsletter with EmailContinue with GoogleOr continue with othersAppleFacebookXBy continuing, I agree to the and CommentsAdd a public comment...PostNo comments yetTop NewsChina Trains Its Sights on U.S. Chips—Signal or Leverage?Jay's Insight2h agoLoading...Stocks Open Higher as AI Optimism and Fed Hopes Buoy Markets; Oil Rises, Gold SteadyWallstreet Insight3h agoLoading...China’s August Data: Softer Pulse, Incremental Easing Likely as U.S.–China Talks LoomJay's Insight4h agoLoading...Related ArticlesGenmab Stock Surges: FDA Breakthrough for Endometrial Cancer TreatmentAInvest08/28Loading...FDA Approves Johnson & Johnson's Inlexzo for Bladder Cancer with 82% Remission RateAInvest09/09Loading...Johnson & Johnson's FDA-Approved Inlexzo: A Game-Changer in Bladder Cancer TreatmentAInvest09/10Loading...Trending NewsTikTok Deal Reached as President Trump Says Trade Talks With China Going 'Very Well'Wallstreet Insight4h agoLoading...Tesla Shares Soar as Musk Buys $1 Billion Stake After 5 Years, Targeting $8.5 Trillion Market Cap PlanWallstreet Insight4h agoLoading...CoreWeave shares jump 7.5% before market close as NVIDIA and company sign $6.3 billion new order4h agoChina Says Nvidia Violated Anti-Monopoly Law in Preliminary Probe, Will Require Further Investigation Amid Trade TalksWallstreet Insight8h agoLoading...Former OpenAI Exec Reveals the Shocking Truth About AI’s FutureAdam Shapiro09/11Loading...IFFCO's $1.5 Billion Debt Restructuring: Implications for UAE's Diversifying Corporate LandscapePhilip Carter09/12Loading...Amazon Bets Big on Crypto with $500K "Ecosystem Lead" GambitCoin World17h agoLoading...China launches Anti-dumping probe against some US chips. - Bloomberg09/13Whales Awaken, Wallets Proliferate: Why Bitcoin's Breakout Could Be InevitableCoin World22h agoLoading...Tesla shares rise 4% pre-market as Musk acquires 2.5 million shares worth $1 billion.7h agoLoading...Stocks Open Higher as AI Optimism and Fed Hopes Buoy Markets; Oil Rises, Gold SteadyWallstreet Insight3h agoLoading...Alkermes' Strategic Licensing of Vivitrol to Amneal: A Calculated Move in a Fragmented Addiction Therapeutics MarketJulian West09/12Loading...RI Mining's Strategic Alignment with Microsoft's AI Infrastructure Expansion: Unlocking Regional Economic Transformation and High-Tech Industrial Opportunities12X Valeria09/14Loading...Trump: I Think We Will Have A Big Cut This WeekWallstreet Insight6h agoLoading...Financial Week Ahead: Fed's Shadow Looms Large as Meta Ready for Connect ConferenceWallstreet Insight16h agoLoading...Disclaimer: The news articles available on this platform are generated in whole or in part by artificial intelligence and may not have been reviewed or fact checked by human editors. While we make reasonable efforts to ensure the quality and accuracy of the content, we make no representations or warranties, express or implied, as to the truthfulness, reliability, completeness, or timeliness of any information provided. It is your sole responsibility to independently verify any facts, statements, or claims prior to acting upon them. Ainvest Fintech Inc expressly disclaims all liability for any loss, damage, or harm arising from the use of or reliance on AI-generated content, including but not limited to direct, indirect, incidental, or consequential damages., NEW HAVEN, Conn., Aug. 08, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), today with its partner Pfizer Inc. (NYSE: PFE), announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for vepdegestrant for the treatment of patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), ESR1-mutated , Arvinas and Pfizer announce the FDA's acceptance of the new drug application for vepdegestrant, a treatment for estrogen receptor-positive/human epidermal growth factor receptor 2-negative, ESR1-mutated advanced or metastatic breast cancer. The FDA has assigned a Prescription Drug User Fee Act action date of June 5, 2026..
NEW HAVEN, Conn. and NEW YORK, May 31, 2025 – Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) today announced detailed results from the Phase 3 VERITAC-2 clinical trial (NCT05654623) evaluating vepdegestrant monotherapy versus fulvestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer (MBC , Arvinas, in collaboration with Pfizer, has announced new drug application (NDA) acceptance for vepdegestrant from the US Food and Drug Administration (FDA) to treat breast cancer. The treatment is aimed at patients with oestrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), oestrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer who have , Arvinas, Inc., in partnership with Pfizer, has announced that the FDA has accepted their New Drug Application for vepdegestrant, an investigational treatment for advanced or metastatic breast cancer with estrogen receptor-positive (ER+)/HER2-negative and ESR1 mutations, specifically for patients who have previously undergone endocrine therapy., The acceptance sets the stage for vepdegestrant to enter a competitive breast cancer treatment landscape. Arvinas is targeting a specific patient subset – those with ESR1 mutations – who often face limited treatment options after initial endocrine therapy and CDK 4/6 inhibitors., NEWS Arvinas and Pfizer Report the US FDA’s NDA Submission of Vepdegestrant for ESR1-Mutated Breast Cancer By Ridhi Rastogi June 9, 2025, Arvinas Announces Submission of New Drug Application to U.S. FDA for Vepdegestrant for Patients with ESR1-Mutated ER+/HER2- Advanced or Metastatic Breast Cancer - June 6, 2025 Vepdegestrant FDA Approval History More news resources FDA Medwatch Drug Alerts Daily MedNews News for Health Professionals New Drug Approvals New Drug Applications Drug .