Longeveron held a Type C meeting with the FDA regarding its Phase 2b ELPIS II trial for laromestrocel, a treatment for hypoplastic left heart syndrome (HLHS). The FDA acknowledged the high unmet need for HLHS therapies but stated that the trial's primary endpoint, right ventricle ejection fraction (RVEF), is not appropriate to demonstrate efficacy. Due to an interim NIH-mandated analysis, the FDA will not agree to a new primary endpoint during the ongoing trial and no longer considers the trial pivotal. However, the FDA is willing to discuss results and potential next steps after trial completion. Longeveron plans to submit a statistical analysis plan with composite endpoints and remains optimistic about filing for FDA approval after top-line results expected in August 2026.
The global automotive microcontrollers market is projected to grow from USD 15.49 billion in 2025 to USD 34.31 billion by 2035, at a CAGR of 8.28%. Growth is fueled by increasing adoption of advanced driver-assistance systems (ADAS), vehicle electrif...
Sodexo has secured a major global contract to provide catering services across more than 130 Meta sites in over 30 countries. This large-scale partnership includes diverse locations such as headquarters, campuses, data centers, and conference centers...
Viasat and BMW Group have successfully demonstrated the first integrated automotive satellite voice call, allowing drivers to make calls directly through the car's infotainment system even in areas without cellular coverage. This advancement, utilizi...
Iran has warned it will retaliate fiercely if the US targets its infrastructure, following President Trump's threat to strike Iranian power plants and bridges next week if negotiations fail. The US recently conducted airstrikes against Iranian milita...
Solana (SOL) maintains its price in the mid-$70 range, supported by several key developments. These include Circle's recent issuance of $500 million in USDC on the Solana network, increasing liquidity and transactional demand. Additionally, instituti...
