FDA's new PreCheck pilot program aims to boost domestic drug manufacturing through streamlined regulatory pathways and early facility engagement.
Roche's investigational obesity drug CT-388 demonstrated 22.5% placebo-adjusted weight loss at 48 weeks in Phase 2 trial, advancing to Phase 3 studies.
The FDA has authorized Visby Medical's at-home test for chlamydia, gonorrhea, and trichomoniasis, marking a major advancement in sexual health testing accessibility.
Lyra Therapeutics halts development of LYR-210 for chronic rhinosinusitis despite positive Phase 3 results, cutting workforce and exploring strategic alternatives.
FDA eliminates mandatory safety program for clozapine, citing access concerns while acknowledging ongoing neutropenia risk for patients.
