Therapeutic or Preventive Procedure
Trinity Biotech Repositions for AI-Driven Growth with CGM+ Biosensor Platform
Trinity Biotech; CGM+; AI-powered healthcare; digital health; continuous glucose monitor; wearable biosensor; multi-sensor data; predictive analytics; personalized medicine; chronic disease management
Galapagos Considers Sale of Cell Therapy Unit in Ongoing Strategic Overhaul
Galapagos; cell therapy; sale; strategic alternatives; pipeline pruning; biotech; spinout; Gilead Sciences; GLPG5101; mantle cell lymphoma; business development
FDA Official Says Sarepta Faces Major Hurdles to Reintroduce DMD Therapy Elevidys
Sarepta; Elevidys; FDA; Duchenne muscular dystrophy; gene therapy; CBER; safety concerns; shipment pause; new studies; approval status
RFK Jr. Approves ACIP Recommendation to Remove Thimerosal from U.S. Flu Vaccines
RFK Jr.; Thimerosal; ACIP; Vaccine Safety
Roche Halts Elevidys Distribution in Several Countries Following Sarepta and FDA Safety Concerns
Roche; Sarepta Therapeutics; Elevidys; Duchenne muscular dystrophy; gene therapy; FDA; shipment halt; safety concerns; patient deaths
Sarepta Halts US Shipments of Duchenne Therapy Elevidys After FDA Pressure
Sarepta Therapeutics; Elevidys; Duchenne muscular dystrophy (DMD); FDA; gene therapy; safety concerns; shipment suspension; patient deaths
Dispatch Bio Launches with $216M and CAR-T Pioneer Carl June to Advance Universal Solid Tumor Immunotherapy
Dispatch Bio; solid tumors; immunotherapy; CAR-T; Carl June; Series A funding; Flare platform; Parker Institute for Cancer Immunotherapy; ARCH Venture Partners; universal cancer treatment
Sarepta Therapeutics Faces FDA Crackdown after Third Patient Death; George Tidmarsh Named Top FDA Drug Regulator; Multiple Drugs Rejected; Pharma Invests Billions in US Manufacturing
Sarepta Therapeutics; FDA; gene therapy; Elevidys; acute liver failure; clinical hold; George Tidmarsh; drug rejection; reshoring; pharmaceutical manufacturing
Lack of Transparency Tarnishes Sarepta’s Sheen as Patient Deaths Trigger FDA Battle
Sarepta Therapeutics; Elevidys; patient deaths; FDA; lack of transparency; gene therapy; market withdrawal; regulatory action; limb-girdle muscular dystrophy (LGMD); Duchenne muscular dystrophy
Scancell’s Cancer Vaccine Supercharges Melanoma Immunotherapy in Recent Trials
Scancell; SCIB1; iSCIB1+; melanoma; cancer vaccine; immunotherapy; checkpoint inhibitors; clinical trial; SCOPE trial