Key Takeaways. LGM Pharma’s Texas expansion targets commercial suppository manufacturing and broader semi-solid/liquid development, aligning with women’s health demand and U.S ...

Gastrointestinal tolerability remained the dominant adverse-reaction cluster, aligning with established GLP‑1 receptor agonist class effects across dose ranges. A higher-dose signal of altered skin ...

FDA’s NAM framework emphasizes context of use, human biological relevance, technical characterization, and fit-for-purpose ...

Taken together, these signals operationalize a data-centric oversight model. They also raise a practical question for CMC and quality leaders: if evidence is increasingly remote-ready and ...

SGD Pharma and Prince launch sterile Type I glass nasal vials for the US market, targeting complex chronic conditions like ...

Chief manufacturing officers must treat slow tech transfer and CDMO onboarding as a strategic liability, given patent cliffs, modality complexity, and China+1 diversification pressures. Agentic AI and ...

Denis Beckford Vera, head of Radiopharmacology, Champion Oncology explains how patient-derived xenografts improve drug ...

FDA's March 2026 draft guidance outlines a validation framework for non-animal drug testing methods, signaling a shift in nonclinical submission expectations.

Icotrokinra is a once-daily, empty-stomach oral peptide that antagonizes IL‑23R, aiming to match biologic pathway selectivity while overcoming historic oral peptide bioavailability barriers. Duplicate ...

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IRA revisions now exempt multi-indication orphan drugs from price negotiations, improving lifecycle economics and encouraging ...

The new €3.2M (US$3.7M) research lab will investigate immunogenic cell death mechanisms in lung cancer to improve how existing therapies trigger immune response.