Nuvation Bio Announces Pivotal Global Phase 3 SIGMA Trial (G203) for Safusidenib in IDH1-Mutant Glioma Nuvation Bio Inc. a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced finalization of a protocol amendment to…
Evinova and Bristol Myers Squibb Forge Strategic Collaboration to Optimize Clinical Development with Artificial Intelligence Evinova today announced that Bristol Myers Squibb has signed an agreement to optimize clinical trials with Evinova’s AI-native clinical development platform. Under the terms of…
Roche’s fenebrutinib becomes the first investigational therapy in over a decade to slow disability progression in primary progressive multiple sclerosis (PPMS) Roche announced today new late-breaking data from the Phase III FENtrepid study showing the investigational Bruton’s tyrosine kinase (BTK)…
Nubeqa™ (Darolutamide) Gains Third Approval in China for Treatment of Advanced Prostate Cancer in Men The Chinese National Medical Products Administration (NMPA) has approved the oral androgen receptor inhibitor (ARi) Nubeqa™ (darolutamide) in combination with androgen deprivation therapy (ADT) for…
Bristol Myers Squibb Launches “Change the Target. Change What’s Possible.” Campaign to Address Unmet Needs in Cardiovascular and Thromboembolic Care Bristol Myers Squibb announced today the launch of “Change the Target. Change What’s Possible.” an educational campaign developed in partnership with Johnson…
Pfizer’s Monthly Ultra-Long-Acting Injectable GLP-1 RA Demonstrates Sustained and Significant Weight Loss in Phase 2b Trial Pfizer Inc. today announced positive topline results from the Phase 2b VESPER-3 study investigating monthly maintenance dosing of its fully-biased, ultra-long-acting, injectable GLP-1 receptor…
Exelixis Announces FDA Acceptance of New Drug Application for Zanzalintinib Combined with Immune Checkpoint Inhibitor in Metastatic Colorectal Cancer Exelixis, Inc. today announced that its New Drug Application (NDA) for zanzalintinib, in combination with atezolizumab (Tecentriq®), has been accepted for…
Finerenone Recommended in the EU for Heart Failure Patients with LVEF ≥40% Bayer today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending finerenone (Kerendia™), a…
Johnson & Johnson Secures CHMP Positive Opinion for AKEEGA®—a Dual-Action Tablet Combining Niraparib and Abiraterone Acetate—for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) in Patients with BRCA1/2 Mutations Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use…
Lilly Establishes New Injectable Medicine and Device ManufacturingLilly Chooses Pennsylvania for New Injectable Medicine and Device Manufacturing Facility Eli Lilly and Company today announced plans to invest more than $3.5 billion in a new manufacturing facility in the Lehigh Valley, Pennsylvania. The site…
WuXi Biologics and Sinorda Biomedicine Forge Strategic Partnership to Advance Development and Manufacturing of Innovative Bispecific Antibodies WuXi Biologics, a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), and Sinorda Biomedicine today jointly announced a strategic collaboration for the…
Biogen’s Litifilimab Earns FDA Breakthrough Therapy Designation for Cutaneous Lupus Erythematosus—First Targeted Therapy on the Horizon Biogen Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for litifilimab (BIIB059) for the treatment of cutaneous…