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 ...

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 ...

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

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 ...

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

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

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 ...

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.

Vinay Prasad will leave FDA CBER by end of April, returning to UCSF after a one-year sabbatical, following a prior departure ...

Sun Pharmaceutical Industries Limited. Sun Pharma announces US FDA acceptance of supplemental Biologics License Application for ILUMYA (tildrakizumab-asmn) for the treatment of adults with active ...