EC approves TREMFYA® for pediatric plaque psoriasis — first IL-23 inhibitor for children Johnson & Johnson today announced that the European Commission (EC) has extended the marketing authorisation for TREMFYA® (guselkumab) as a subcutaneous treatment to treat moderate to severe Pediatric plaque…
WuXi Biologics Earns Top “A” Ratings from CDP for Climate Change and Water Security WuXi Biologics announced that it has been named to the CDP “A” lists for both Climate Change and Water Security for 2025, underscoring its leadership in…
Johnson & Johnson Secures FDA Approval for TRUFILL n-BCA Liquid Embolic System to Treat Symptomatic Chronic Subdural Hematoma Johnson & Johnson MedTech, a leader in neurovascular care, announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication…
CDC Officially Approves Delayed Hepatitis B Vaccine Dose The CDC has accepted the recommendation of its vaccine advisory committee and ended the three-decade-long practice of giving most newborn children a birth dose of the hepatitis B vaccine.The change in recommendation, announced Tuesday, leaves the…
BlueRock Therapeutics’ Investigational Cell Therapy Bemdaneprocel for Parkinson’s Disease Granted Pioneering Regenerative Medical Product Designation in Japan Bayer AG and its wholly owned, independently operated subsidiary BlueRock Therapeutics LP, a clinical stage cell therapy company, today announced that the investigative…
Enhertu plus pertuzumab approved in the U.S. as the first new first-line treatment in a decade for HER2-positive metastatic breast cancer AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been approved in the US for the 1st-line treatment…
Cytokinetics Announces Positive CHMP Opinion for MYQORZO® in Obstructive HCM Cytokinetics, Incorporated today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization in the…
Updated Data for Lilly’s Inluriyo™ (imlunestrant) Reinforce Efficacy as Monotherapy and in Combination with Verzenio® (abemaciclib) in ER+, HER2– Advanced Breast Cancer Eli Lilly and Company today announced updated results from the Phase 3 EMBER-3 study of Inluriyo (imlunestrant), an…
Bio-Techne Collaborates with Wyss Center Geneva to Drive Innovation in Automated 3D Multiomics and Accelerate Spatial Biology Research Bio-Techne Corporation, a global provider of life science tools, reagents, and diagnostic products, today announced a strategic collaboration between one of its…
Blujepa (gepotidacin) Receives US FDA Approval as Oral Treatment for Uncomplicated Urogenital Gonorrhea (uGC) GSK plc today announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application for gepotidacin as an oral option for…
FDA Grants Priority Review to Bristol Myers Squibb’s Opdivo® (nivolumab) Plus Chemotherapy for Classical Hodgkin Lymphoma Bristol Myers Squibb today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to the supplemental Biologics License…
Roche Expands Automated Mass Spectrometry Portfolio with CE Mark Approval for Antibiotic Drug Monitoring, Delivering the Industry’s Broadest IVD Menu Roche announced today that it has secured CE Mark approval for its mass spectrometry reagent pack for antibiotics drug monitoring.…
