Marco Anelli, MD | Authors | Pharmaceutical Technology serves as the connection to bio manufacturing and development, featuring regulatory updates and expert industry news.
The FDA cleared four notable therapies within the same week in late August, spanning infectious disease, cardiometabolic care ...
In December 2025, FDA announced that it was deploying agentic AI capabilities across the agency. FDA defined these systems as ...
This article explores strategies for formulating complex and emerging biologics, the role of predictive modeling, and ...
FDA approves Rasonque (daraxonrasib), the first broad RAS-targeted therapy for metastatic pancreatic cancer, validating RAS ...
Continuous direct compression can provide a simplified alternative pathway for selected spray-dried dispersion formulations ...
In part 2 of his overview on hold times in biopharmaceuticals, Robert Dream details the regulations that govern hold times ...
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.
McKesson plans to absorb Precision Medicine Group into Oncology & Multispecialty, adding CRO, lab, biomarker, market access, and commercialization capabilities to its existing healthcare services ...
Schmitt and Schniepp stress that merely citing a standard (e.g., "we followed GAMP") doesn't guarantee compliance. According ...
Centrix and University of Sussex launch a data analytics partnership to reduce development risk, rework and delays in early-stage pharma programs. A collaboration between Centrix Pharma Solutions, a ...
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