Search Results
Aug 20, 2026, 08:30 ET Planning for Accelerated Approval: Timing is Everything, Upcoming Webinar Hosted by Xtalks
speakers will discuss recent FDA changes, confirmatory trial strategy, protocol design, inspection readiness and chemistry, manufacturing and controls (CMC) planning. Attendees will also explore how coordinating clinical, regulatory and operational activities earlier can help reduce development risk and
More news about: Xtalks
Aug 19, 2026, 03:00 ET QC Ware Announces 2026 Q2B Copenhagen Conference Focused on the Roadmap to Quantum Value in Europe and Beyond
Microsoft QuantumEllen Devereux – CTO Advisor for Quantum, FujitsuAnders Broo – Senior CMC Project Leader, AstraZenecaOn day two, Steven Camp, Managing Director, Quantum Investment Banking at Needham & Company, will host a
More news about: QC Ware Corp.
Aug 18, 2026, 16:10 ET Kennametal Names Dawne Hickton and Richard Harshman to its Board of Directors
defense and energy markets. RTI was acquired by Alcoa in 2015.Hickton currently serves on the Board of Directors of Commercial Metals Company (CMC) and chairs the Board of Directors at Elevra Lithium. She has served on multiple public and private company boards, including Jacobs, Haynes International,
More news about: Kennametal Inc.
Aug 17, 2026, 11:07 ET L7 Informatics Unveils L7|ESP® 2026.1, Solidifying the Premier Agentic Operating System for Precision Sciences
intelligence directly onto its existing unified architecture. The release enables global enterprises to bridge gaps across research, process development (CMC), formulation, tech transfer, and clinical/commercial manufacturing within their internal and external supply chains using the LIMS, ELN, MES, and Scheduling
More news about: L7 Informatics
Aug 13, 2026, 08:30 ET CMC Strategy in Biologics: Decisions With Downstream Consequences, Upcoming Webinar Hosted by Xtalks
In this free webinar, learn how early CMC decisions can affect later manufacturing and development timelines. The featured speakers will discuss common problems across cell line development, process design, formulation and analytics, and how to match CMC strategy to a program's stage and goals. Attendees
More news about: Xtalks
Aug 12, 2026, 16:05 ET Armata Pharmaceuticals Announces Financial Results for the Second Quarter 2026 and Provides a Corporate Update
incorporating all comments received in the End-of-Phase 2 ("EOP2") meeting written response.Chemistry, Manufacturing, and Controls ("CMC")Submitted responses to all FDA comments raised in the EOP2 meeting written response.Completed the validation and
More news about: Armata Pharmaceuticals, Inc.
Aug 12, 2026, 16:01 ET PTC to Expand Rare Disease Portfolio with Acquisition of BLA-Stage ST-920 Fabry Disease Program
evidence to support traditional approval. The nonclinical and clinical BLA modules have already been submitted as part of a rolling submission, with the CMC package expected to be submitted in Q4 2026. PTC will also pursue regulatory approval outside of the United States, again leveraging existing regulatory
More news about: PTC Therapeutics, Inc.
Aug 12, 2026, 10:31 ET CAR T-Cell Therapy for Acute Lymphoblastic Leukemia Market to Grow Significantly at a CAGR of 6.8% During the Forecast Period (2026-2036), Driven by Emerging Therapies and Expanding Pipeline | DelveInsight
that the FDA has selected its investigational allogeneic CAR-T cell therapy, Sofi-cel, for participation in the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program. The company was invited to join the initiative, which annually selects up to nine development programs
More news about: DelveInsight Business Research, LLP
Aug 12, 2026, 08:30 ET Improve Drug Solubility from Formulation to Scale-Up, Upcoming Webinar Presented by Quotient Sciences and NGT Biopharma Consultants, Hosted by Xtalks
Quotient Sciences; Mark A. Krook, PhD, CMC & Early Drug Development, NGT Biopharma Consultants; and Andrew Parker, PhD, Executive Drug Development Consultant, Quotient Sciences, as they explore
More news about: Xtalks
Aug 11, 2026, 08:31 ET Ceramedix Awarded Up to $4.5 Million NIAID Contract to Advance Lead GI-ARS Therapeutic Toward IND Submission
Health (NIH). The contract will fund Ceramedix's continued nonclinical in vivo studies and advance the Chemistry, Manufacturing and Controls (CMC) development of its lead drug candidate, a proprietary, first-in-class anti-ceramide antibody designed to disrupt microvascular cell death signaling.
More news about: Ceramedix, Inc.
Aug 09, 2026, 22:26 ET HanchorBio and Taiwan Cancer Moonshot Project-NTU Subteam Led by Professor Sung-Liang Yu Establish Strategic Collaboration to Advance Precision Oncology
designed to address significant unmet medical needs through differentiated molecular configurations, translational development strategies, and scalable CMC capabilities. For more information, please visit: https://www.HanchorBio.comForward-Looking
More news about: HanchorBio Inc.
Aug 06, 2026, 19:00 ET Energenesis Biomedical and Taiwan Tanabe Seiyaku Enter Joint Development Agreement for ENERGI-F703DFU
KEY HIGHLIGHTSJoint development program to support process technology transfer and chemistry, manufacturing and controls (CMC) preparation for a potential new drug application (NDA) in Taiwan.The parties plan to evaluate subsequent manufacturing and commercialization
More news about: Energenesis Biomedical Co., Ltd.
Aug 06, 2026, 07:55 ET KOPPERS REPORTS SECOND QUARTER 2026 RESULTS
gains in the competitive markets we serve. On the cost side, we are accelerating the previously announced closure of our Carbon Materials and Chemicals (CMC) plant located at Stickney, Illinois, and advancing the Railroad and Utility Products and Services (RUPS) network optimization efforts to improve utilization
More news about: KOPPERS HOLDINGS INC.
Aug 05, 2026, 08:00 ET A New Biopharma Roadmap: Zifo's SiEE Basel Event Puts Data Before AI Hype
challenges. Core discussions centred on establishing strict master data governance, scaling automated workflows at the cyber-physical interface, standardizing CMC data pipelines, and preparing organizational cultures for advanced applications like closed-loop science and digital twins.To watch the sessions,
More news about: Zifo
Aug 05, 2026, 08:00 ET Porton Advanced Secures Drug Manufacturing License (Class C), Expanding CDMO Services to Commercialization
has developed specialized CRO and CDMO platforms focusing on plasmids, viral vectors (lentiviral vector, adenoviral vector, AAV, etc.), cell therapy CMC services including CAR-T, TCR-T, CAR-NK, HSC, exosome, etc., bacterial vector and nucleic acid therapies. Our state-of-the-art, GMP-compliant facilities
More news about: Porton Advanced
Aug 05, 2026, 06:49 ET CMC Highlights Position as a Leading, Early-Stage Construction Solutions Provider and Unveils Long-Term Financial Targets at 2026 Investor Day
CMC Investor Day 2026. A replay of the webcast and accompanying materials will be available following the event.About CMCCMC is a Fortune 500 company headquartered in Irving, Texas, and a leading provider
More news about: CMC
Aug 05, 2026, 06:45 ET CMC Announces $600 Million Increase in Share Repurchase Program Authorization
IRVING, Texas, Aug. 5, 2026 /PRNewswire/ -- CMC (NYSE: CMC) (the "Company" or "CMC") today announced that its Board of Directors has authorized a $600.0 million increase in the Company's existing common stock repurchase program,
More news about: CMC
Aug 05, 2026, 03:00 ET NueCell Bio Announces its Launch as a New Translational Partner for Cell Therapies with Unique Expertise to Accelerate Treatments from Discovery into GMP Manufacturing
supported by modular technology stacks that can be tailored to each program.NueCell Bio gives clients access to experienced design, development and CMC expertise. By combining scientific excellence, strong quality systems, scalable operations, and 'customer-first' engagement, NueCell Bio helps accelerate
More news about: NueCell Bio
Aug 05, 2026, 03:00 ET NueCell Bio Announces its Launch as a New Translational Partner for Cell Therapies with Unique Expertise to Accelerate Treatments from Discovery into GMP Manufacturing
supported by modular technology stacks that can be tailored to each program.NueCell Bio gives clients access to experienced design, development and CMC expertise. By combining scientific excellence, strong quality systems, scalable operations, and 'customer-first' engagement, NueCell Bio helps accelerate
More news about: NueCell Bio
Aug 04, 2026, 13:00 ET Black Clover USA and Topgolf Announce 5-Year Marketing, Retail and Apparel Sponsorship Program
nationwideCo-branded hats with dedicated retail racks at each venueBranded tees and polos exclusive to Topgolf playersGolf headcovers and gloves from CMC Design, a Black Clover Enterprises brandThe partnership extends into Topgolf Media Networks, the company's newly launched sponsorship, media
More news about: Topgolf
Aug 04, 2026, 08:55 ET NYSE Content Update: ADI to Make NYSE Trading Debut After Spin-Off
BellADI Global Distribution (NYSE: ADIG) celebrates becoming a public companyClosing BellCommercial Metals (NYSE: CMC) rings the NYSE Closing BellFor market insights, IPO activity, and today's opening bell, download the NYSE TV App:
More news about: New York Stock Exchange
Aug 04, 2026, 08:21 ET FDA Grants Fast Track Designation to Xellsmart Off-The-Shelf Cell Therapy for Parkinson's Disease
complete in-house infrastructure, consisting of a 5,000 m² R&D center, a B+A grade GMP production plant and a dedicated QC laboratory. It has completed CMC development for several clinical-grade iPSC cell candidates, and established end-to-end clinical cell production workflows alongside strict quality management
More news about: XellSmart Biopharmaceutical Co., Ltd.
Aug 03, 2026, 08:17 ET Genezen and the Raiden Science Foundation Announce Partnership for AAV9 Gene Replacement Therapy for UBA5 Clinical Trial
platform analytical vector-specific methods, and specialty in ultra-rare therapy manufacturing. Genezen has proven experience with agile, risk-based CMC frameworks tailored to enable rapid development and clinical delivery of personalized gene therapies."We are inspired by the Pham family's resilience
More news about: Genezen
Aug 03, 2026, 08:00 ET cAMPfield Strengthens Leadership Team with Key Executive Appointments, Including Graham Heap, MD, PhD as President, R&D, to Advance Prifemilast into Global Phase 2 Development for Inflammatory Bowel Disease
Head of Early Phase Product Development at Neurocrine Biosciences, he served as a global program and CMC lead across multiple small-molecule, peptide, and gene therapy programs, and contributed to the CMC regulatory filings supporting approved therapies including Ingrezza® (valbenazine) and Crenessity®
More news about: cAMPfield Therapeutics
Jul 31, 2026, 20:25 ET Alabama-Based Simparo Inc. Earns Fourth U.S. Patent, Backed by Innovate Alabama Investment
The newly issued patent addresses a long-standing challenge in Thumb CMC reconstruction: achieving basal joint reconstruction quickly, securely, and reproducibly. Conventional approaches often require second site tendon harvesting,
More news about: Simparo Surgical