-
Mesoblast Receives BLA Filing Number and Requests Modular Review for Rexlemestrocel-L in Patients with End-Stage Heart Failure and LVADs
June 30, 2026 20:38 ET | Source: Mesoblast Limited NEW YORK, June 30, 2026 (GLOBE NEWSWIRE) — Mesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has received a Biologics License Application (BLA) filing number from the U.S. Food and Drug Administration (FDA) and has requested a…
-
REPROCELL Submits Application for Manufacturing and Marketing Approval in Japan for Stem Cell Therapy Stemchymal® for Spinocerebellar Ataxia (SCA3 and SCA6)
YOKOHAMA, Japan, June 24, 2026 /PRNewswire/ — REPROCELL Inc. today announced the submission of an application for manufacturing and marketing approval in Japan for the regenerative medicine product Stemchymal®, for which the company holds exclusive commercialization rights in Japan. The application seeks approval for the use of Stemchymal® to suppress the progression of ataxia in…
-
Nicox Announces Positive Pre-submission Regulatory Feedback in China Supporting NDA filing for NCX 470
Press Release Nicox Announces Positive Pre-submission Regulatory Feedback in China Supporting NDA filing for NCX 470 Exclusive licensee for China, Ocumension, received positive pre-submission regulatory feedback from the Chinese Center for Drug Evaluation (CDE) for NCX 470 Based on this feedback, Ocumension intends to proceed with the New Drug Application (NDA) submission in China Submission…
-
Fireaway Achieves Type Approval and EU/UK Marine Equipment Certification for Stat-X® Condensed Aerosol Fire-Extinguishing Systems Following MSC.1/Circ.1270 Evaluation
Three certificates issued by Bureau Veritas support application in SOLAS-regulated marine environments across global, EU-flagged, and UK-flagged vessels. MINNETONKA, Minn., June 9, 2026 /PRNewswire/ — Fireaway Inc. today announced that its Stat-X® condensed aerosol fire-extinguishing systems have received type approval from Bureau Veritas following evaluation in accordance with MSC.1/Circ.1270. Three certificates covering the global market,…
-
WaveMaker Fuses Design and Development with Architecture-first Agentic Application Generation System for Enterprise Dev Teams
Brings deterministic outcomes and low, predictable costs to AI-assisted development for businesses Bengaluru, Karnataka, India; Plano, Texas , United States WaveMaker, a leading application platform provider for enterprise-grade web and mobile applications, today announced the availability of its new agentic application generation system, designed to target a growing need for a standardized AI-powered development model…
Latest News
About the Author
We increase the awareness of millions of users through our news networks. We are one of the most trusted news networks in the world.
