Cover storyFDA’s Proposed DTC Rule would remove the adequate provision option for broadcast drug ads, requiring full risk information in every spot. See what pharma leaders can do now.
FDA converts pembrolizumab's TMB-H approval to traditional status, raising the biomarker threshold from ≥10 to ≥13 mut/Mb and narrowing patient eligibility.
Genentech's KRAS breakthrough creates formulation and process validation challenges for oncology CDMOs and plant operations teams.
FDA's NAIN initiative aligns CBER, CDER, and CDRH on CNS product development, launching with an Alzheimer's Prevention Accelerator.
AbbVie's lutikizumab met the HiSCR75 primary endpoint and 8 secondary endpoints in Phase 3 INTREPID, signalling a likely BLA submission path.
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