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-funded DHT projects at MGH, Biosensics, and U of Rochester advance wearable endpoint validation for ALS, CMT, and Huntington's disease submissions.
FDA grants accelerated approval for Voceryq, the first plasmid DNA-based immunotherapy in the U.S., raising immediate GMP and CBER inspection implications.
FDA updates minocycline breakpoints for Stenotrophomonas maltophilia; regulatory teams must review labeling alignment with new MIC and disk diffusion thresholds.
Viatris commences $36.50/share tender offer for Pacira BioSciences, with liposomal manufacturing integration posing key GMP and quality system implications.
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