United States Food and Drug Administration
Boehringer Ingelheim’s Nerandomilast Succeeds in Second Phase III Lung Fibrosis Trial, Paving Way for FDA Approval
Nerandomilast, Boehringer Ingelheim, Phase III trial, FIBRONEER-ILD, progressive fibrosing interstitial lung diseases (PF-ILDs), lung function improvement, FDA approval, phosphodiesterase 4B (PDE4B) inhibitor
Fourth Patient Receives Gene-Edited Pig Kidney in Groundbreaking Clinical Trial
xenotransplantation, clinical trial, gene-edited pig kidney, FDA approval, United Therapeutics, eGenesis, end-stage renal disease, organ shortage
Trump Administration Targets Massive Cuts to Federal Health Workforce
federal health workers, layoffs, Trump administration, HHS, FDA, healthcare agencies, workforce reduction, government downsizing
Kura Oncology and Kyowa Kirin Report Positive Phase 2 Results for Ziftomenib in AML, Prepare for FDA Submission
Ziftomenib, AML, NPM1-mutant, Phase 2 trial, KOMET-001, FDA submission, Kura Oncology, Kyowa Kirin
FDA Approves Onapgo: Breakthrough Infusion Device for Advanced Parkinson’s Disease
Onapgo, apomorphine hydrochloride, Parkinson’s disease, subcutaneous infusion, motor fluctuations, FDA approval, Supernus Pharmaceuticals
FDA Approves Roche’s Susvimo for Diabetic Macular Edema: A Breakthrough in Continuous Delivery Eye Treatment
Susvimo, ranibizumab, diabetic macular edema, DME, Roche, FDA approval, continuous delivery, eye implant, vision improvement
FDA Halts Amgen’s Phase 1 Obesity Drug Trial: AMG 513 Study on Hold
Amgen, obesity drug, AMG 513, FDA clinical hold, Phase 1 trial, pharmaceutical setback
FDA Approves Vertex’s Journavx: First Non-Opioid Pain Medication in Decades
Journavx, suzetrigine, non-opioid, acute pain, FDA approval, Vertex Pharmaceuticals, pain management, opioid alternative
J&J’s Subcutaneous Rybrevant Receives CHMP Backing for Lung Cancer Treatment Despite Recent FDA Rejection
Rybrevant, amivantamab, Johnson & Johnson, CHMP, FDA, subcutaneous formulation, non-small cell lung cancer, EGFR mutations
FDA Approves Roche’s PATHWAY HER2 Test for HER2-Ultralow Metastatic Breast Cancer
Roche, PATHWAY HER2 (4B5) test, FDA approval, HER2-ultralow, metastatic breast cancer, companion diagnostic, Enhertu, personalized medicine