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.…
TUKYSA Added to First-Line Maintenance Therapy Boosts Median Progression-Free Survival by More Than 8 Months in HER2+ Metastatic Breast Cancer Patients Pfizer Inc. today announced detailed results from the Phase 3 HER2CLIMB-05 trial of the tyrosine kinase inhibitor TUKYSA® (tucatinib) as…
Roche’s Giredestrant Lowers Risk of Invasive Disease Recurrence or Death by 30% in Early-Stage ER-Positive Breast Cancer Roche announced today positive data from the phase III lidERA Breast Cancer study evaluating investigational giredestrant as an adjuvant endocrine treatment for people…
AskBio’s AB-1005 and AB-1002 Granted Pioneering Regenerative Medicine Product Designation in Japan AskBio Inc., a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW)…
Novartis’ Ianalumab Provides Sustained Disease Control in Immune Thrombocytopenia Patients with Just Four Monthly Doses Novartis today announced positive results from VAYHIT2, a Phase III trial evaluating ianalumab plus eltrombopag in patients with primary immune thrombocytopenia (ITP) previously treated with corticosteroids1-3.…
Lilly to Invest $6 Billion in Alabama Facility for Active Pharmaceutical Ingredient Production Eli Lilly and Company today announced plans to invest more than $6 billion in a new manufacturing facility in Huntsville, Alabama. This next-generation synthetic medicine active pharmaceutical ingredient (API) facility, the…
