EU green light to IntraBio’s AQNEURSA for rare neurological disease Niemann-Pick Type C
The approval is grounded in data from a Phase III randomized, double-blind, placebo-controlled, crossover study in NPC patients
The approval is grounded in data from a Phase III randomized, double-blind, placebo-controlled, crossover study in NPC patients
The RMAT designation accelerates the development of regenerative medicine therapies for serious or life-threatening diseases
The development marks an important step in Sigachi's strategic focus on expanding its presence in complex, high-value specialty APIs, aligned with global demand for advanced therapies in rare and chronic disease segments
The partnership aims to fuse Avantium’s breakthrough materials with Packamama’s expertise in low-emission, innovative wine bottles
The BD Neopak Glass Prefillable Syringe platform is designed for the complex needs of biologics and combination products
Iktos will deploy its AI-driven tools to accelerate the identification of optimized small-molecule candidates against a currently undisclosed oncology target
BFF provides bookable fermentation upscaling capacity, process expertise, and quality procedures for pilot campaigns, generating decision-grade data without companies needing to build their own facilities
CHOMax integrates cell line development, process development, analytics, and GMP manufacturing under robust quality processes
The multimillion-dollar facility combines discovery and early-phase scale-up capabilities with R&D labs and two pilot plants
New 35,000-square-foot facility in Winter Park will expand RLT manufacturing footprint to optimize delivery for patients across southeastern US
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