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May 06, 2026, 10:30 ET Image Analysis Group (IAG) and HeartcoR Solutions Announce Strategic Partnership to Deliver Integrated Cardiac Safety and Imaging Core Lab Services for Clinical Trials
advisory services to pharmaceutical, biotechnology and medical device companies. IAG's proprietary DYNAMIKA™ platform delivers GxP‑validated, FDA 21 CFR Part 11‑compliant imaging data management and analysis for clinical trials across oncology, musculoskeletal, autoimmune, neurological and cardiovascular
More news about: HeartcoR Solutions
May 05, 2026, 09:00 ET Made Scientific and RoosterBio Announce Strategic Technology and Supply Partnership to Expand Scalable MSC and Extracellular Vesicle Manufacturing
off-the-shelf cGMP master and working cell banks are derived from US-sourced donor tissue per AATB, AABB, and FDA regulations and in accordance with 21CFR1271. This combined experience creates a derisked path to IND approval and subsequent clinical advancement. "This partnership gives our clients
More news about: Made Scientific, Inc.
May 05, 2026, 09:00 ET RoosterBio and Made Scientific Announce Strategic Technology and Supply Partnership to Expand Scalable MSC and Extracellular Vesicle Manufacturing
off-the-shelf cGMP master and working cell banks are derived from US-sourced donor tissue per AATB, AABB, and FDA regulations and in accordance with 21CFR1271. This combined experience creates a derisked path to IND approval and subsequent clinical advancement. "This partnership gives our clients
More news about: RoosterBio, Inc.
May 04, 2026, 17:04 ET Cellenkos Announces FDA Clearance of Investigational New Drug (IND) Application for Phase 1b/ 2a Trial of CK0802 in Steroid-Refractory Graft-versus-Host Disease (GVHD)
respiratory complications of the virus.About CK0802Derived from qualified U.S. public cord blood units in compliance with 21 CFR Part 1271, CK0802 is a pioneering, "off-the-shelf" cryopreserved Treg therapy. Featuring a robust shelf life of nearly three years, this investigational
More news about: Cellenkos, Inc.
May 04, 2026, 16:40 ET Cellenkos Announces FDA Clearance of Investigational New Drug (IND) Application for Phase 1b/ 2a Trial of CK0802 in Steroid-Refractory Graft-versus-Host Disease (GVHD)
respiratory complications of the virus.About CK0802Derived from qualified U.S. public cord blood units in compliance with 21 CFR Part 1271, CK0802 is a pioneering, "off-the-shelf" cryopreserved Treg therapy. Featuring a robust shelf life of nearly three years, this investigational
More news about: Cellenkos, Inc.
May 01, 2026, 13:02 ET ZETA SURGICAL® Receives FDA 510(k) Clearance Expanding Access to Brain Tumor Biopsies, Hydrocephalus, and Trigeminal Neuralgia
Bolt, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The device is classified as a Class II stereotaxic instrument (21 CFR 882.4560) under product code HAW (K253663).
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Apr 30, 2026, 16:25 ET Cullen/Frost Bankers, Inc. reschedules earnings conference call
SAN ANTONIO, Texas, April 30, 2026 /PRNewswire/ -- Cullen/Frost Bankers, Inc. (NYSE: CFR) will host a conference call on Thursday, April 30, 2026 to discuss first quarter 2026 earnings.Earnings Release: The
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Apr 30, 2026, 09:00 ET CULLEN/FROST REPORTS FIRST QUARTER RESULTS
Preferred Stock (or $0.278125 per depositary share). The depositary shares representing the Series B Preferred Stock are traded on the NYSE under the symbol "CFR PrB." The Series B Preferred Stock dividend is payable June 15, 2026 to shareholders of record on May 29 of this year.Cullen/Frost Bankers, Inc.
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Apr 30, 2026, 06:00 ET Ascent Aviation Services Expands Widebody MRO Capabilities and Enters New Phase of Growth
line, storage, and reclamation services to owners, operators, and lessors of wide-body, narrow-body, and regional aircraft. Ascent is a Class IV FAA 14 CFR Part 145 certified repair station and has maintained a strong and continuous workforce in Arizona for over 40 years. For more information, visit
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Apr 30, 2026, 05:33 ET eSignGlobal更名為eSign.AI,開啟AI原生合同自動化的新篇章
在合規性方面,eSign.AI擁有ISO 27001、ISO 27701和ISO 27018認證,並支持包括美國《電子簽名法》(ESIGN Act)/《統一電子交易法》(UETA)、歐盟eIDAS法規、《健康保險便攜性和責任法案》(HIPAA)、《通用數據保護條例》(GDPR)和 21 CFR Part 11在內的主要監管框架,為跨境協議提供端到端的法律保障。其基礎設施依托位於香港、新加坡和德國法蘭克福的獨立數據中心,滿足各司法管轄區的數據主權要求,並通過全棧HTTPS和AES-256加密,全面保護傳輸中和靜態數據的安全。
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Apr 29, 2026, 18:20 ET Bird-X Unveils Two Game-Changing Handheld Lasers That Send Pest Birds Fleeing on Sight
HH-100 is Bird-X's entry-level professional platform, rated at 100 mW output power and classified as a Class 3B laser device per IEC 60825-1:2014 and 21 CFR Chapter 1. Daytime coverage extends to 100 meters (328 feet) under standard ambient lighting conditions; nighttime coverage exceeds 1,000 meters (3,280
More news about: Bird-X, Inc
Apr 29, 2026, 09:00 ET IBRX Investor Alert: ImmunityBio Securities Fraud Lawsuit - Investors With Losses May Seek to Lead the Class Action After Company Allegedly Promoted Unapproved Drug Uses: Levi & Korsinsky
drug has no approvalThe podcast was allegedly not submitted to the FDA at the time of initial dissemination as required by 21 CFR 314.81(b)(3)(i)What Management Allegedly KnewThe lawsuit asserts that the Company's leadership was aware, or
More news about: Levi & Korsinsky
Apr 29, 2026, 08:30 ET Strengthen Readiness for a Potential SAS-to-R Shift in Data Analytics, Upcoming Webinar Hosted by Xtalks
ecosystems and AI-enabled workflows.Importantly, this webinar will address the key concerns that often arise in regulated settings: validation, 21 CFR Part 11 compliance, auditability, package control and long-term sustainability. Rather than framing the discussion as a binary "R vs. SAS" debate, this
More news about: Xtalks
Apr 28, 2026, 08:30 ET How AI Can Reduce Inspection Risk and Strengthen QMSR Readiness, Upcoming Webinar Hosted by Xtalks
significant changes to medical device regulation in decades. Attendees will gain a better understanding of validated digital systems aligned with 21 CFR Part 11 and GAMP 5. The featured speakers will discuss integrating ISO 14971 risk management throughout the QMS lifecycle. Attendees will also gain insight
More news about: Xtalks
Apr 27, 2026, 06:47 ET Cellenkos, Inc. Announces FDA Clearance to Initiate Phase 2 Clinical Trial of CK0801 (Allogeneic Cord Blood-Derived Tregs) for Aplastic Anemia
collected and banked from a healthy normal donor who has met FDA requirements for screening and testing for transmissible disease, in compliance with 21 CFR Part 1271, Subpart C. The FDA previously granted
More news about: Cellenkos, Inc.
Apr 27, 2026, 06:21 ET Cellenkos, Inc. Announces FDA Clearance to Initiate Phase 2 Clinical Trial of CK0801 (Allogeneic Cord Blood-Derived Tregs) for Aplastic Anemia
collected and banked from a healthy normal donor who has met FDA requirements for screening and testing for transmissible disease, in compliance with 21 CFR Part 1271, Subpart C. The FDA previously granted
More news about: Cellenkos, Inc.
Apr 23, 2026, 09:00 ET IBRX Lawsuit Alleges Company Allegedly Violated Drug Promotion Laws - ImmunityBio Investors Face Losses Following Company Allegedly Violated Drug Promotion Laws: SueWallSt
to submit the podcast to FDA at the time of initial dissemination, violating 21 CFR 314.81(b)(3)(i) failed to submit the podcast to FDA at the time of initial dissemination, violating 21 CFR 314.81(b)(3)(i)FD&C Act Violations and Investor HarmThe
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Apr 22, 2026, 11:57 ET Global Cloud ELN Service Market | USA, China, India Lead | Thermo Fisher Scientific, Agilent Technologies, Dassault Systèmes Drive Digital Lab Transformation
systems to cloud-native platforms is improving efficiency and data accuracyRegulatory Compliance Pressure: Standards such as FDA 21 CFR Part 11, GLP/GMP, and HIPAA are driving demand for secure and auditable ELN systemsGlobal Collaboration Needs: Cloud ELNs enable real-time
More news about: Future Market Insights
Apr 21, 2026, 11:00 ET ALKU Opens West Coast Office to Expand Life Sciences Staffing Services.
AffairsAutomation, controls, and manufacturing systems (DeltaV, Rockwell, SCADA, etc.)Computer System Validation (CSV), Data Integrity, and 21 CFR Part 11 complianceCapital projects, facility expansions, and tech transfer supportProject and program managementManufacturing,
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Apr 20, 2026, 03:05 ET Labbit Goes All-In on LIMS Platform, Retires Semaphore Solutions Brand
supports complex biologic workflows, GMP environments, and quality control process digitalization, with regulatory and security credentials including 21 CFR Part 11 readiness, SOC 2 Type II certification, and HIPAA compliance.Existing customers and partners will see no changes to their service, support,
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Apr 17, 2026, 05:54 ET Notizie da Artmarket.com: Artprice conferma il successo di Artprice News, la prima agenzia di stampa al mondo totalmente dedicata all'arte e al suo mercato, in 11 lingue e 122 paesi, con Cision PR Newswire e X
suo dipartimento Artprice sono stati fondati nel 1997 da Thierry Ehrmann, CEO dell'azienda. Sono controllati dal Groupe Serveur (fondato nel 1987). cfr. la biografia certificata da Who's Who In France©:
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Apr 14, 2026, 20:00 ET 沃特世推出業界首款適用於 UHPLC/UPLC 的寬範圍 MALS 分析系統,助力大分子快速表徵
分析系統搭載了擁有 40 餘年光散射創新技術的 ASTRA™ 軟體。透過將 MALS 與紫外 (UV) 偵測及示差折光 (RI) 偵測相結合,ASTRA 軟體可採用針對 ADC、LNP 和病毒載體的專用流程,在單次運行中全面分析樣品尺寸、組成及異質性。該平台符合 21 CFR Part 11 與 EU Annex 11 法規要求,並計劃於今年稍晚推出相容 Waters Empower™ 軟體的版本。Waters omniDAWN MALS 分析系統將於 2026 年夏季在全球上市。如需了解更多資訊或申請產品展示,請造訪
More news about: Waters Corporation
Apr 14, 2026, 13:57 ET Global CMO/CDMO Market Set for Steady Growth as Biologics Outsourcing and Specialized Manufacturing Drive Demand | Future Market Insights (FMI)
and ComplianceStringent global standards continue to shape the market. CDMOs must maintain:cGMP compliance (FDA 21 CFR Parts 210/211)EU GMP (EudraLex Volume 4)ICH guidelines and multi-region certificationsData integrity and traceability systemsCompanies
More news about: Future Market Insights
Apr 14, 2026, 08:00 ET Waters Debuts Industry-First Extended-Range MALS Detector for UHPLC/UPLC, Powering Rapid Characterization of Large Molecules
comprehensive analysis of size, composition, and heterogeneity in a single run, with dedicated workflows for ADCs, LNPs, and viral vectors. The platform is 21 CFR Part 11 and EU Annex 11 compliant and will be compatible with Waters Empower™ Software later this year.The Waters omniDAWN MALS Photometer will
More news about: Waters Corporation
Apr 14, 2026, 08:00 ET Waters Debuts Industry-First Extended-Range MALS Detector for UHPLC/UPLC, Powering Rapid Characterization of Large Molecules
comprehensive analysis of size, composition, and heterogeneity in a single run, with dedicated workflows for ADCs, LNPs, and viral vectors. The platform is 21 CFR Part 11 and EU Annex 11 compliant and will be compatible with Waters Empower™ Software later this year.The Waters omniDAWN MALS Photometer will
More news about: Waters Corporation