Thermo Fisher GENESYS G5: Expandable Software on Proven UV-Vis
Thermo Fisher launches the GENESYS G5 series of UV-Vis spectrophotometers, built around software modularity and accessory expansion rather than headline optics specs.
EquipmentFDA Approves Lipfendra, First Oral PCSK9 Inhibitor for High Cholesterol
FDA approves Lipfendra (enlicitide), the first oral PCSK9 inhibitor, as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia including HeFH.
InstitutionsWHO-UNICEF: Child Immunization Coverage Edges Up but Measles Outbreaks Persist
Global childhood vaccination rates inch forward with 90% of infants receiving DTP1, but rising dropout and 57 measles outbreak countries signal persistent gaps.
InstitutionsUnchained Labs Launches Lil' Tuna Benchtop Buffer Exchange System
Unchained Labs launches Lil' Tuna, a compact automated plate-based buffer exchange system combining Big Tuna throughput and Unagi flexibility for every lab scale.
EquipmentFDA Proposes Rule to Modernize Drug Manufacturing Registration
FDA proposes streamlined registration for distributed drug manufacturers and clarifies foreign facility requirements under the PREVENT Pandemics Act.
InstitutionsEMA Fast Tracks Review of Daraxonrasib for Metastatic Pancreatic Cancer
EMA's CHMP starts phased review of daraxonrasib, a medicine for metastatic pancreatic cancer, to accelerate assessment for patients with limited treatment options.
InstitutionsMarketing Authorisation for Tavneos (Avacopan) Recommended for Revocation
CHMP recommends revoking Tavneos' EU marketing authorisation after finding that the pivotal Advocate study data are incorrect and misleading due to GCP breaches.
InstitutionsFDA Approves First Gene Therapy for Young Children with Sickle Cell Disease
FDA issues supplemental approval for Casgevy, the first CRISPR/Cas9 gene therapy, for patients 2 years and older with sickle cell disease or transfusion-dependent beta thalassemia.
InstitutionsFDA Approves First Treg Cell Therapy to Prevent Chronic GVHD in Blood Cancer
FDA approves Tregzi, the first regulatory T cell-based immunotherapy, to improve chronic graft-versus-host disease-free survival in adults with blood cancers undergoing stem cell transplantation.
InstitutionsFDA Approves First Single-Dose Generic Treatment for Influenza
FDA approves first generic of Xofluza (baloxavir marboxil), the first single-dose generic treatment for acute uncomplicated influenza and prophylaxis in patients 5 years and older.
InstitutionsFDA Approves Tzield (teplizumab) for Pediatric Stage 3 Type 1 Diabetes
FDA grants accelerated approval to Tzield (teplizumab) to delay decline of insulin production in pediatric patients ages 8–17 with recently diagnosed Stage 3 type 1 diabetes.
InstitutionsFDA Broadens Access to Over-the-Counter Naloxone Nasal Spray for Opioid Overdose
FDA approves Rextovy, another over-the-counter naloxone nasal spray for emergency treatment of opioid overdose, broadening access and consumer options.
Institutions