Regulatory News & FDA Approvals The latest regulatory news and FDA approvals. Jan 24, 2023 Geneoscopy Submits PMA Application to FDA for Stool-Based Colorectal Cancer Screening Test Jan 20, 2023 Astellas' Zolbetuximab Plus Chemo Benefits CLDN18.2-Positive, HER2-Negative Gastric Cancer Patients Premium Jan 20, 2023 FDA Approves Seagen's Tukysa, Genentech's Herceptin for HER2-Positive Colorectal Cancer Patients Jan 19, 2023 In Brief This Week: Strata Oncology, Orphagen Pharmaceuticals, Hutchmed, MD Anderson Cancer Center Jan 17, 2023 Lantern Pharma Preparing IND for Synthetic Lethality Program With FDA Feedback Jan 13, 2023 In Brief This Week: Legend Biotech, Point Biopharma, AstraZeneca, Daiichi Sankyo, Takeda, Micronoma Jan 11, 2023 JP Morgan Healthcare Conference, Day 2: Roche, Zai Lab, Revolution Medicines, Ideaya Biosciences Jan 11, 2023 Natera Eyes Regulatory Path for Signatera as Companion Diagnostic Jan 10, 2023 Immunocore Unveils New T-Cell Receptor Therapy Candidates, Estimates $140M in 2022 Kimmtrak Sales Jan 10, 2023 Prenetics' ACT Genomics Profiling Test for Solid Tumors Receives FDA Clearance Jan 9, 2023 Ideaya to Launch PARG Inhibitor Trial in Homologous Recombination Repair-Deficient Cancers Jan 6, 2023 In Brief This Week: Datar Cancer Genetics, Daiichi Sankyo, ProPhase Labs, Innovent Biologics Jan 4, 2023 FDA Approves Foundation Medicine Blood Test as CDx for Rozlytrek Jan 4, 2023 Absent Resolution on FDA's LDT Oversight in 2022, Some Payors Began Advancing Their Own Requirements Premium Jan 3, 2023 China's NMPA Accepts New Drug Application for Legend Biotech, Janssen's Carvykti Dec 22, 2022 FDA Clears Iaso Biotherapeutics for US Trials of BCMA-Targeted CAR-T Therapy in Multiple Myeloma Dec 21, 2022 FDA Approves Foundation Medicine Assay as CDx for Certain NSCLC Therapies Dec 20, 2022 Invectys, CTMC Begin First-in-Human Trial of HLA-G-Targeting CAR T-Cell Therapy in Solid Tumors Dec 20, 2022 NICE Backs Enhertu via Managed Access Program for Certain HER2-Positive Breast Cancer Patients Dec 19, 2022 FDA Updates Xeloda Labeling to Make DPYD Variant Risks More Explicit Load More Breaking News Ratio Therapeutics Raises $20M in Series A Financing Guardant Health, AnHeart Tx to Develop Blood- and Tissue-Based CDx for NSCLC Drug Ellipses Pharma Cleared by FDA to Open Phase I/II AML Trial Survey Reveals Changing Genetic Testing Patterns, Persistent Disparities in Precision Oncology Amgen's Lumakras Sales Increased 58 Percent in Q4 2022 Coeptis Therapeutics, University of Pittsburgh Studying SNAP-CAR Therapy in HER2-Positive Cancers What's Popular? In Regulatory News & FDA Approvals Menarini's Orserdu, Guardant's ctDNA CDx Net FDA Approval for ESR1-Mutated Breast Cancer Patients NICE Backs Gilead Sciences' Yescarta as Third-Line Option for Lymphoma Patients JP Morgan Healthcare Conference, Day 2: Roche, Zai Lab, Revolution Medicines, Ideaya Biosciences Immunocore Unveils New T-Cell Receptor Therapy Candidates, Estimates $140M in 2022 Kimmtrak Sales Janssen, Legend Biotech's Carvykti Bests Chemo in Earlier-Line Multiple Myeloma Trial
