
enGene’s Detalimogene Shows Improved Six-Month Complete Response Rate of 62%
enGene Reports Updated LEGEND Phase 2 Data Showing 62% Complete Response Rate at Six Months for Detalimogene Voraplasmid in BCG-Unresponsive NMIBC enGene Holdings Inc. (Nasdaq: ENGN) (“enGene” or the “Company”),…

FDA Approves Promega OncoMate MSI Dx as Companion Test for KEYTRUDA + LENVIMA in Endometrial Cancer
FDA Approves Promega OncoMate® MSI Dx Analysis System as Companion Diagnostic for KEYTRUDA® Plus LENVIMA® in Advanced Endometrial Carcinoma The U.S. Food and Drug Administration (FDA) has officially approved the…

Samsung Epis Holdings Launches Epis NexLab to Drive Next-Gen Biotech Innovation
Samsung Epis Holdings Launches Epis NexLab to Pioneer Next-Generation Biotech Platforms and Drive Global Innovation Samsung Epis Holdings Co., Ltd. has officially announced the establishment of Epis NexLab Co., Ltd.,…

Arcturus Therapeutics Reports Third Quarter 2025 Financial Results and Pipeline Updates
Arcturus Therapeutics Reports Third Quarter 2025 Financial Results and Provides Key Corporate Updates Arcturus Therapeutics Holdings Inc. (“Arcturus” or the “Company”) (Nasdaq: ARCT), a commercial-stage messenger RNA (mRNA) medicines company…

PharmaEssentia USA Appoints Dr. Barry Flannelly as Independent Director
PharmaEssentia USA Appoints Dr. Barry Flannelly as Independent Director, Strengthening Leadership Amid Expanding Global Ambitions PharmaEssentia USA Corporation, a wholly owned subsidiary of PharmaEssentia Corporation (TWSE: 6446), today announced the…

TFDA Approves Orphan Drug Designation for Tinostamustine in Malignant Glioma
FDA Grants Orphan Drug Designation to Tinostamustine for the Treatment of Malignant Glioma Purdue Pharma L.P. (“Purdue”) today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan…

CuraSen Reports Positive Phase 1 Data for CuraAX (CST-3056) at 2025 AAS Symposium
CuraSen Therapeutics Presents Positive Phase 1 Data Demonstrating Safety, Pharmacokinetics, and Pharmacodynamics of CuraAX (CST-3056) at the 2025 American Autonomic Society International Symposium CuraSen Therapeutics, Inc., a privately held biopharmaceutical…

Revvity, MDIC, and NIST Launch Somatic Cancer Reference Standards to Ensure Diagnostic Accuracy
Revvity Launches Next-Generation Somatic Cancer Reference Standards in Collaboration with MDIC and NIST Revvity, Inc. today announced the release of its new, highly characterized Mimix™ Geni™ somatic cancer reference standards,…

City Therapeutics Submits Clinical Trial Application for CITY-FXI
City Therapeutics Submits Clinical Trial Application for CITY-FXI, an Investigational RNAi Therapeutic Targeting Factor XI for the Treatment of Thromboembolic Diseases City Therapeutics, Inc., a pioneering biopharmaceutical company focused on…

Kardigan Reports Positive Phase 2 Results for Ataciguat in Aortic Stenosis
Kardigan Showcases Positive Phase 2 Data for Ataciguat in Moderate Calcific Aortic Valve Stenosis at AHA Scientific Sessions 2025 Kardigan, a cardiovascular-focused biotechnology company working to modernize drug development for…

Onchilles Pharma Publishes ELANE Pathway Study, Advances N17350 With New Funding
Onchilles Pharma Publishes Landmark ELANE Pathway Study, Advances N17350 Toward Clinical Development With New Financing and Strategic Clinical Expertise Onchilles Pharma, a privately held biotechnology company developing a new class…

CrossBridge Bio Named “Best Drug Developer” at 2025 World ADC Awards
CrossBridge Bio Awarded “Best Drug Developer” at the 2025 World ADC Awards, Celebrating Breakthrough Innovation in Dual-Payload ADCs CrossBridge Bio, an emerging biopharmaceutical innovator specializing in the development of next-generation…
