United States Food and Drug Administration
FDA Approves SpringWorks’ Gomekli for Adult and Pediatric NF1-PN Patients
Gomekli, mirdametinib, neurofibromatosis type 1, plexiform neurofibromas, FDA approval, SpringWorks Therapeutics, MEK inhibitor
Vertex COO Stuart Arbuckle to Retire as Company Launches Groundbreaking Pain Drug Journavx
Vertex Pharmaceuticals, Stuart Arbuckle, retirement, Journavx, non-opioid pain medication, FDA approval, acute pain treatment
FDA Issues Import Alerts for Two Chinese API Manufacturers Following Failed Inspections
FDA, import alert, Chinese API manufacturers, failed inspections, quality control, Wuhu Nuowei Chemistry, Chengdu Innovation Pharmaceutical
Hims & Hers Super Bowl Ad Sparks Controversy Over Weight Loss Drug Marketing
Hims & Hers, Super Bowl ad, weight loss drugs, FDA scrutiny, compounded GLP-1 drugs, pharmaceutical advertising, telehealth, consumer safety
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