FDA imposed a clinical hold on RGX-121 after spine MRI surveillance detected asymptomatic spinal nodules/cystic masses in five participants dosed intracisternally or intraventricularly 3–6 years prior ...
Pharma industry experts indicate that strategy in 2026 is shifting to agentic AI, sustainable efficiency, and resilient supply chains to manage tariffs, regulations, and digitalization. To formulate a ...
Chris Williams serves as executive director, Analytical Development ILM at Alcami, bringing more than a decade of experience ...
Schmitt and Schniepp stress that merely citing a standard (e.g., "we followed GAMP") doesn't guarantee compliance. According ...
On August 19,2026, the FDA accepted Teva Pharmaceuticals' New Drug Application (NDA) for ecopipam, an investigational ...
David S. Thompson, CSAP, is Chief Alliance Officer at Eli Lilly and Company.
A dual delivery capsule platform provides delivery of multiple APIs with a single dosage unit, which reduces pill burden and simplifies dosing regimens.
Ryan Swanson, PhD, director of process development, Lifecore Biomedical, connected with PharmTech to discuss the formulation ...
Accelerated approval relies on cornstarch-reduction as a surrogate endpoint, with crossover follow-up planned at 96 and 144 ...
For peptide programs, then, nitrosamine strategy is likely to succeed only when it is embedded inside broader analytical ...
Lifecore Biomedical's Ryan Swanson, PhD, explains how material conservation, viscosity, and sterility assurance shape high-concentration biologic formulation.
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