Pink SheetThe first meeting of the US Food and Drug Administration’s Genetic Metabolic Diseases Advisory Committee will be heavy on temporary voting members, several of whom are veterans of the adcomm process.
Medtech InsightLegislators instructed the US Food and Drug Administration to “suspend” implementation of the final rule on lab-developed tests in the FDA funding bill for fiscal 2025, which passed out of the House A
Pink SheetHouse appropriators continue to amplify lawmaker concerns that the application review practices of US Food and Drug Administration’s drug and biologics centers are inconsistent. The report , released
Pink SheetThe saga of the ALS treatment Relyvrio may be generating ripple effects across the disease landscape. Alon Ben-Noon, CEO of NeuroSense Therapeutics Ltd. , which is developing PrimeC as an amyotrophic