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 ...

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 ...

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

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 ...

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.

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 ...

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 ...

European Commission approval enables 2 mg/kg Q4W pegunigalsidase alfa for stable, ERT-treated adults, extending infusion intervals from Q2W to Q4W to lessen cumulative treatment burden. Evidence ...