Lonza will add commercial-scale manufacturing for highly complex HPAPIs and ADC payload linkers at Visp, expanding capacity ...

This week, the industrialization of advanced biologics, sustained regulatory and investment momentum behind next-generation therapeutics, and an ongoing push across the supply chain to improve ...

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US opens Section 301 probe into Germany's drug pricing, threatening tariffs that could disrupt API supply chains and reshape ...

FDA authorized the first generic baloxavir marboxil, a cap-dependent endonuclease inhibitor, expanding single-dose influenza ...

The authors describe the background and applications of fully formulated aqueous shellac for film-coating systems. Shellac is a polymer used in coating applications to provide various functional ...

As Eli Lilly moves forward with its $3.5 billion injectable medicines facility in the Lehigh Valley region of Pennsylvania, ...

A Class II recall was initiated for duloxetine lots after N-nitroso-duloxetine exceeded FDA intake limits, reflecting low acute clinical risk but regulatory nonconformance. Nitrosamine issues ...

In this episode of Drug Digest, experts from Sanofi, GxP Frame, and Open Biopharma explain how AI is transforming drug discovery, manufacturing, and workforce strategy and how strategic partnerships ...

The selection of an appropriate salt form for a potential drug candidate is an opportunity to modulate its characteristics to improve bioavailability, stability, manufacturability, and patient ...

FDA’s durable expectation is that AI outputs can aid drafting, but must be reviewed and cleared by an authorized QU ...

High-concentration injectable formulations present unique challenges. Poor solubility issues are often associated with small-molecule APIs formulated for oral administration. Solubility is also ...