Key Takeaways. LGM Pharma’s Texas expansion targets commercial suppository manufacturing and broader semi-solid/liquid ...
FDA’s NAM framework emphasizes context of use, human biological relevance, technical characterization, and fit-for-purpose ...
Denis Beckford Vera, head of Radiopharmacology, Champion Oncology explains how patient-derived xenografts improve drug ...
SGD Pharma and Prince launch sterile Type I glass nasal vials for the US market, targeting complex chronic conditions like ...
Gastrointestinal tolerability remained the dominant adverse-reaction cluster, aligning with established GLP‑1 receptor ...
IRA revisions now exempt multi-indication orphan drugs from price negotiations, improving lifecycle economics and encouraging ...
Vinay Prasad will leave FDA CBER by end of April, returning to UCSF after a one-year sabbatical, following a prior departure ...
Icotrokinra is a once-daily, empty-stomach oral peptide that antagonizes IL‑23R, aiming to match biologic pathway selectivity ...
Chief manufacturing officers must treat slow tech transfer and CDMO onboarding as a strategic liability, given patent cliffs, ...
Taken together, these signals operationalize a data-centric oversight model. They also raise a practical question for CMC and ...
The new €3.2M (US$3.7M) research lab will investigate immunogenic cell death mechanisms in lung cancer to improve how ...
Sun Pharmaceutical Industries Limited. Sun Pharma announces US FDA acceptance of supplemental Biologics License Application ...
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