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.
Mineralys Therapeutics presents Phase 3 lorundrostat data showing BP and albuminuria reductions in CKD patients ahead of a December 2026 PDUFA date.
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.
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