Biopharma | December 16, 2025
FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission
If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease
If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease
Dr Srivastava was selected by an expert jury in recognition of her sustained contributions to renewable chemicals, industrial biotechnology and bioprocess innovation
Clinical trial enrollment has long been a bottleneck in drug development
All pending litigation between Biocon Biologics, Regeneron, and Bayer will be dismissed
These building blocks are essential to modern therapeutics, including fast-growing GLP-1 treatments for weight loss and diabetes
This partnership strengthens LMS as a leading CDMO supplier of peptide materials for both innovator and generic markets
Formycon AG will develop, register, manufacture and supply the product, while Zydus Lifesciences Global FZE, United Arab Emirates will be responsible for the commercialization of FYB206 in the defined territories
The agreement pairs Croda’s global footprint and “smart science” approach with Amino’s precision manufacturing capabilities
The new site will produce next-generation synthetic medicine active pharmaceutical ingredients
Zyrifa is indicated for patients with bone metastases stemming from a wide range of solid tumors
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