FDA’s Proposed DTC Rule Could End TV Drug Ads

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.