World News

The U.S. Food and Drug Administration (FDA) recently approves an updated label for UNLOXCYT based on long-term follow-up data from the pivotal CK-301-101 clinical trial.

The company recently filed a New Drug Application (NDA) with the U.S. Food and Drug Administration for its first BFS-based prefilled injection device, achieving a major regulatory breakthrough for the platform.

This collaboration delivers crucial funding to Agenus while simultaneously securing sustained biologics manufacturing capacity within the United States.

Penumbra shareholders will have the option to receive either USD374 in cash or 3.8721 Boston Scientific shares, with the transaction structured as approximately 73% cash and 27% stock.

The company plans to bring Neopak Glass Prefillable Syringe production to its long-established facility in Columbus, Nebraska.

The ACCESS-AD project launches in January 2026 with an ambitious goal to establish a collaborative, patient-centered approach to Alzheimer’s care throughout Europe.

Caldera raised USD75 million in a Series A financing round led by Atlas Venture, LAV, and venBio, followed by an additional USD37.5 million in a Series A-1 round led by Omega Funds.

The site will house the company’s signature technology: the fully automated Cell Shuttle production platform alongside Cell Q quality control systems.

The companies unveiled their partnership at the 2026 J.P. Morgan Healthcare Conference, which took place from January 12 to 15 in San Francisco.

This new 35,000 square foot, purpose-built site represents Novartis’s fourth dedicated RLT facility.