United States Food and Drug Administration
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
FDA Approves Vertex’s Journavx: A Breakthrough Non-Opioid Pain Medication
Journavx, suzetrigine, Vertex Pharmaceuticals, FDA approval, non-opioid pain reliever, acute pain treatment, NaV1.8 inhibitor
FDA Approves Axsome’s Symbravo for Rapid Migraine Relief
Symbravo, meloxicam, rizatriptan, FDA approval, acute migraine treatment, rapid-acting, Axsome Therapeutics