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  • Regulatory

enGene’s Detalimogene Shows Improved Six-Month Complete Response Rate of 62%

  • The Pharma Data
  • November 12, 2025

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”),…

Read MoreenGene’s Detalimogene Shows Improved Six-Month Complete Response Rate of 62%
  • News

FDA Approves Promega OncoMate MSI Dx as Companion Test for KEYTRUDA + LENVIMA in Endometrial Cancer

  • The Pharma Data
  • November 12, 2025

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…

Read MoreFDA Approves Promega OncoMate MSI Dx as Companion Test for KEYTRUDA + LENVIMA in Endometrial Cancer
  • Research

Samsung Epis Holdings Launches Epis NexLab to Drive Next-Gen Biotech Innovation

  • The Pharma Data
  • November 12, 2025

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.,…

Read MoreSamsung Epis Holdings Launches Epis NexLab to Drive Next-Gen Biotech Innovation
  • Business

Arcturus Therapeutics Reports Third Quarter 2025 Financial Results and Pipeline Updates

  • The Pharma Data
  • November 11, 2025

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…

Read MoreArcturus Therapeutics Reports Third Quarter 2025 Financial Results and Pipeline Updates
  • News

PharmaEssentia USA Appoints Dr. Barry Flannelly as Independent Director

  • The Pharma Data
  • November 11, 2025

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…

Read MorePharmaEssentia USA Appoints Dr. Barry Flannelly as Independent Director
  • Press Releases

TFDA Approves Orphan Drug Designation for Tinostamustine in Malignant Glioma

  • The Pharma Data
  • November 11, 2025

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…

Read MoreTFDA Approves Orphan Drug Designation for Tinostamustine in Malignant Glioma
  • Business

CuraSen Reports Positive Phase 1 Data for CuraAX (CST-3056) at 2025 AAS Symposium

  • The Pharma Data
  • November 11, 2025

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…

Read MoreCuraSen Reports Positive Phase 1 Data for CuraAX (CST-3056) at 2025 AAS Symposium
  • Regulatory

Revvity, MDIC, and NIST Launch Somatic Cancer Reference Standards to Ensure Diagnostic Accuracy

  • The Pharma Data
  • November 11, 2025

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,…

Read MoreRevvity, MDIC, and NIST Launch Somatic Cancer Reference Standards to Ensure Diagnostic Accuracy
  • Research

City Therapeutics Submits Clinical Trial Application for CITY-FXI

  • The Pharma Data
  • November 11, 2025

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…

Read MoreCity Therapeutics Submits Clinical Trial Application for CITY-FXI
  • NewsRegulatory

Kardigan Reports Positive Phase 2 Results for Ataciguat in Aortic Stenosis

  • The Pharma Data
  • November 8, 2025

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…

Read MoreKardigan Reports Positive Phase 2 Results for Ataciguat in Aortic Stenosis
  • Business

Onchilles Pharma Publishes ELANE Pathway Study, Advances N17350 With New Funding

  • The Pharma Data
  • November 8, 2025

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…

Read MoreOnchilles Pharma Publishes ELANE Pathway Study, Advances N17350 With New Funding
  • Regulatory

CrossBridge Bio Named “Best Drug Developer” at 2025 World ADC Awards

  • The Pharma Data
  • November 8, 2025

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…

Read MoreCrossBridge Bio Named “Best Drug Developer” at 2025 World ADC Awards
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