regulatory_compliance

Dallas – September 13, 2026 -- The U.S. Food and Drug Administration has accepted and filed the Biologics License Application for MOGENRY, an optogenetic gene therapy from Nanoscope Therapeutics designed to restore vision in retinitis pigmentosa patients with severe vision loss. If approved, MOGENRY would become the first gene-agnostic treatment available for this patient population, which currently has no approved therapy.

RESTORE trial data anchors the regulatory filing

The BLA is supported by the Phase 2b/3 RESTORE trial (NCT04945772), a multicenter, randomized, double-masked, sham-controlled study that met its primary and key secondary endpoints, showing improvements in visual acuity at weeks 52 and 76. No treatment-related serious adverse events were reported. Additional efficacy and safety data come from the earlier Phase 1/2a trial (NCT04919473).

Singapore – September 13, 2026 -- TÜV SÜD has opened its new Global Decarbonisation Centre of Excellence (CoE) in Singapore, backed by an investment exceeding $24 million with support from the Singapore Economic Development Board (EDB).

Investment builds on SustainCERT acquisition to scale digital carbon verification

The Munich-based testing and certification group launched the CoE following its recent acquisition of Luxembourg-based SustainCERT, an accredited validation and verification body specializing in digital measurement, reporting and verification (dMRV). The combined capabilities target carbon data integrity, carbon markets and independent assessment services as governments prepare to implement Article 6 of the Paris Agreement.

Wilmington, Massachusetts – – September 13, 2026 -- Stafford Manufacturing Corp. has released a full line of shaft collars, couplings, and flange mounts engineered specifically for conveyor and packaging equipment in the food and beverage sector, targeting operators that require frequent wash-down cycles under USDA and FDA compliance standards.

New product line fits round, square and hex bores across multiple materials

The Stafford Shaft Collars, Couplings & Flange Mounts are machined from 303 and 316 stainless steel, food-grade Blue Acetal, Nylon, or Delrin, paired with 18-8 or 316 stainless steel fasteners. The components are available in one- and two-piece designs, giving equipment manufacturers flexibility for assembly and maintenance without full shaft disassembly.

Almaty – September 11, 2026 -- The Bulat Utemuratov Foundation has allocated 460 million tenge (approximately $1 million) to fund the gasification of private housing in Almaty, partnering with the city's Akimat to expand urban infrastructure and cut winter air pollution.

Foundation and city sign MoU covering inspections, consultations and gas connections

Under the recently signed memorandum of understanding, the Almaty Akimat will conduct inspections of private homes, advise residents on connection procedures and provide end-to-end support for switching to natural gas heating. Licensed contractors will then carry out the required construction and installation work.

Taipei – September 12, 2026 -- HanchorBio Inc. (TWSE: 7827) said the U.S. Food and Drug Administration has cleared its HCB101 Single-Patient Expanded Access Protocol (HCB101-EA-001) as "safe to proceed," allowing a Phase 1 patient who showed clinical benefit to continue receiving the investigational drug beyond the parent trial.

FDA authorizes continued treatment for a single Phase 1 patient

The clearance permits the patient to keep receiving HCB101 outside the standard clinical trial structure under the FDA's Expanded Access, or compassionate use, framework. The agency's review weighed the patient's clinical circumstances, including whether the potential benefit justified the risks given the severity of the disease. HanchorBio noted the determination applies only to this individual-patient protocol and does not constitute approval of HCB101 or an FDA finding on its broader safety or efficacy.

Norwalk, Conn. – September 12, 2026 -- Bitmine Immersion Technologies (NYSE: BMNR) disclosed that its total crypto, cash and marketable securities holdings reached $15.7 billion as of September 7, 2026, driven by an Ethereum treasury of 5,929,198 ETH tokens valued at $2,495 per coin.

The holding equals 4.9% of ETH's total 122.0 million token supply, putting the company 97% of the way toward its stated goal of acquiring 5% of all Ethereum in circulation just 15 months after launching its treasury strategy on June 30, 2025.

Bitmine's stock ranks fourth among Russell 1000 gainers with a 99% quarterly return

Chairman Thomas Lee said four of the top 21 performing stocks in the Russell 1000 since June 30 are crypto-related, with Bitmine common shares posting a 99% gain versus the index's 3% return. The company joined the Russell 1000 Large-cap index on June 26, 2026, and its Series A preferred shares trade on the NYSE under ticker BMNP.

New York – September 12, 2026 -- Cerberus Capital Management has agreed to acquire a substantial part of the Mechanical Engineering Division of Goodwin plc for a headline cash consideration of up to approximately £1.1 billion, subject to customary purchase price adjustments. The deal is expected to close in the first quarter of 2027, pending regulatory approvals and other customary closing conditions.

Deal covers five businesses serving global defense and nuclear markets

The transaction includes Goodwin Steel Castings Limited, Goodwin International Limited, Noreva GmbH, Easat Group, and the Pump Division. These units supply proprietary design, advanced manufacturing, and technical expertise to aerospace and defence, nuclear, power, and mining customers worldwide.

Abu Dhabi – September 12, 2026 -- Assets under management at Abu Dhabi Global Market (ADGM) surged 54% year-on-year in the first half of 2026, while the financial center's workforce grew to 49,027 professionals and active licenses climbed to nearly 14,000.

ADGM's fund management ecosystem expands sharply in H1 2026

The number of fund and asset managers based at ADGM reached 190, up 23% from 154 in H1 2025, with 11 new managers added in the second quarter alone -- the largest quarterly increase on record. Funds managed from ADGM rose 32% to 276, from 209 a year earlier. Asset managers that established operations at ADGM in H1 2026 collectively administer global assets exceeding $2.1 trillion.

Düsseldorf – September 12, 2026 -- More than half of German industrial companies have assigned internal teams to prepare their connected products for the EU Cyber Resilience Act (CRA), while over 60 percent are also turning to external specialists, according to the new "IoT & OT Cybersecurity Report 2026" from Düsseldorf-based cybersecurity firm ONEKEY. The findings are based on a survey of 200 German industrial companies regarding CRA readiness.

One-fifth of firms have launched full internal CRA teams

Twenty percent of surveyed companies have set up a dedicated internal team to adapt their product range to CRA requirements, while another third have partially assigned staff to the task. Team size varies sharply: 28 percent have assembled groups of up to ten people, and 22 percent have staffed even larger teams. Sixteen percent manage with three or fewer specialists, and 19 percent have assigned no one at all to the issue.

Menlo Park, Calif. – – September 12, 2026 -- A new report from the Ethical AI Governance Group (EAIGG) and Draup argues that national AI advantage depends on strategic interdependence rather than complete technological self-sufficiency, challenging a core assumption driving global AI policy.

Report introduces scorecard ranking five national AI ecosystems

The AI Sovereignty Paradox: Why AI Advantage Depends on Interdependence unveils the Global AI Adoption Scorecard, a framework assessing national AI readiness across talent, infrastructure, data ecosystems, innovation, capital formation, and policy. The inaugural study benchmarks five ecosystems—the United States, Israel, France, India, and Japan—to determine how AI capability converts into economic and strategic advantage.