The FDA’s recent layoffs are causing delays in the inspection of overseas drug manufacturers. This slowdown raises concerns about medication safety. ProPublica reported on July 7 that the FDA has let go of dozens of individuals responsible for coordinating complex inspections abroad. Although some staff have been rehired, the disruption continues to affect the inspection…

Plus Therapeutics has received FDA approval to start the ReSPECT-LM dose optimization trial for its drug, REYOBIQ™, aimed at treating leptomeningeal metastases. The trial’s primary goal is to establish the optimal dosing schedule for a future registrational trial. This new study builds on the recommended Phase 2 dose identified in a completed Phase 1 trial….