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 ...
SGD Pharma and Prince launch sterile Type I glass nasal vials for the US market, targeting complex chronic conditions like ...
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 ...
Denis Beckford Vera, head of Radiopharmacology, Champion Oncology explains how patient-derived xenografts improve drug ...
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 ...
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 ...
Vinay Prasad will leave FDA CBER by end of April, returning to UCSF after a one-year sabbatical, following a prior departure ...
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.
FDA approves leucovorin for cerebral folate deficiency, signaling how literature-based evidence can support rare disease approvals without clinical trials.
Some results have been hidden because they may be inaccessible to you
Show inaccessible results