Liz CareyRegulatory GuidanceFDA to discuss phaseout enforcement discretion for LDTsIn relation to its proposed medical device rule targeting laboratory developed tests (LDTs), the U.S. Food and Drug Administration (FDA) will hold a webinar Tuesday, October 31, at 1 p.m. EST.October 26, 2023Research and DevelopmentCMS opens new doors for cell and gene therapy under MedicaidA new Medicaid-focused Innovation Center model encourages agreements between pharmaceutical companies and states for cell and gene therapies (CGT).October 18, 2023Previous PagePage 3 of 3Top StoriesFDA ClearanceAmgen gets FDA approval for small cell lung cancer therapyAmgen announced on Thursday that the U.S. Food and Drug Administration (FDA) has approved its therapy tarlatamab, to be marketed under the name Imdelltra, for the treatment of extensive-stage small cell lung cancer (ES-SCLC).Artificial IntelligenceBacklog of unresolved medical diagnoses leads to new method for clinical exome reanalysisStockT2 Biosystems to sell $8M in stock in private placementFDA Warning LetterFDA issues warning for Cue Health COVID-19 testsSponsor ContentVisit our Molecular Diagnostics Community