Clinical Trial News Archive - October 2023
October 2, 2023
- Novartis Investigational Iptacopan Phase III Study Demonstrates Clinically Meaningful and Highly Statistically Significant Proteinuria Reduction in Patients with IgA Nephropathy (IgAN)
- Syndax Announces Pivotal AUGMENT-101 Trial of Revumenib in Relapsed/Refractory KMT2Ar Acute Leukemia Meets Primary Endpoint and Stopped Early for Efficacy Following Protocol-Defined Interim Analysis
- Takeda Provides Update on Voluntary Withdrawal Exkivity® (mobocertinib)
- Acurx Pharmaceuticals Announces Successful Completion and Early Discontinuation of the Ibezapolstat Phase 2b Trial for Treatment of C. difficile Infection
- R21/Matrix-M™ Malaria Vaccine with Novavax’s Adjuvant Technology Receives WHO Recommendation
- Avenge Bio Receives FDA Fast Track Designation for AVB-001, a Novel Cell Therapy Leveraging the LOCOcyte™ Immunotherapy Platform
- U.S. Food and Drug Administration Issues Complete Response Letter for Lebrikizumab Based on Inspection Findings at Third-Party Manufacturer
October 3, 2023
- Takeda’s Dengue Vaccine Recommended by World Health Organization Advisory Group for Introduction in High Dengue Burden and Transmission Areas in Children Ages Six to 16 Years
- Following Pre-NDA Meeting with the FDA, UroGen Announces Rolling NDA Submission for UGN-102 to Begin January 2024
- RedHill and U.S. Army Announce Opaganib's Ebola Virus Disease Survival Benefit in U.S. Army-Funded In-Vivo Study
- Novavax 2023-2024 COVID-19 Vaccine Now Authorized and Recommended for Use in the U.S.
October 4, 2023
- FDA Takes Steps to Advance the Development of Novel Therapies for Stimulant Use Disorders
- Nature Publishes Discovery and Preclinical Results for ABBV-CLS-484, a Potential First-in-Class PTPN2/N1 Inhibitor in Cancer Immunotherapy
- Inhibikase Therapeutics Receives FDA Orphan Drug Designation for Risvodetinib for the Treatment of Multiple System Atrophy
October 5, 2023
- Fostrox + Lenvima continues to show promising tumor control in Hepatocellular Carcinoma
- Innate Pharma Provides Update on Lacutamab Clinical Program
October 7, 2023
October 9, 2023
- First Patient Dosed in the Phase 3 Clinical Study of Efdamrofusp Alfa For the Treatment of Neovascular Age-related Macular Degeneration
- Xenon Pharmaceuticals Announces Publication of Results from XEN1101 Phase 2b "X-TOLE" Clinical Trial in Peer-Reviewed Journal Article in JAMA Neurology
- Supernus Resubmits NDA for SPN-830 Apomorphine Infusion Device
- MBX Biosciences Doses First Participant in Phase 1/2 Clinical Trial of MBX 1416 for the Treatment of Post-Bariatric Hypoglycemia
October 10, 2023
- SELLAS Receives FDA Orphan Drug Designation for SLS009 for Treatment of Acute Myeloid Leukemia
- Alkermes to Present First Clinical Data for Orexin 2 Receptor Agonist ALKS 2680
October 11, 2023
October 12, 2023
- South Rampart Pharma Receives U.S. FDA Fast Track Designation for SRP-001 for Acute Pain
- PepGen Inc. Announces FDA has Lifted the Clinical Hold on its Investigational New Drug Application for FREEDOM-DM1 Phase 1 Study of PGN-EDODM1 for Myotonic Dystrophy Type 1 (DM1)
- Theratechnologies Announces Dosing of First Patient in Updated Clinical Trial of Sudocetaxel Zendusortide in Advanced Ovarian Cancer
- NIH Researchers Work to Preserve Fertility for People Undergoing Gene Therapy
- MimiVax Granted Fast Track Designation from FDA for SurVaxM for Newly Diagnosed Glioblastoma
- Lilly's Mirikizumab Helped Patients with Crohn's Disease Achieve Long-Term Remission in Phase 3 Trial
October 13, 2023
- Investigational Drug Restores Parathyroid Function in Rare Disease
- Late-Breaking Data for Genentech’s BTK Inhibitor Fenebrutinib Show Brain Penetration and Significant Reduction in Lesions in Patients With Relapsing Multiple Sclerosis
- LEO Pharma Presents Phase 3 Results of Delgocitinib Cream for Adults with Moderate to Severe Chronic Hand Eczema
October 14, 2023
- Verastem Oncology Announces Initial Results of RAMP 203 Trial of Avutometinib and Lumakras™ (sotorasib) in KRAS G12C-Mutant Non-Small Cell Lung Cancer
- Trevi Therapeutics Announces Results from Phase 2b/3 PRISM Open-Label Extension Study of Haduvio in Prurigo Nodularis
October 16, 2023
October 17, 2023
- Diakonos Oncology Awarded FDA Fast Track Designation for Innovative Dendritic Cell Vaccine for Glioblastoma
- Clinical Trial Finds Live Vaccinations Safe for Liver, Kidney Transplant Recipients
- Takeda Announces Topline Results of Phase 3 ADMIRE-CD II Trial of Alofisel® (darvadstrocel) in Complex Crohn’s Perianal Fistulas
October 19, 2023
- FDA Grants Fast Track Designation to ANPD001, Autologous Investigational Cell Therapy for the Treatment of Parkinson's Disease
- Nanoformed TargTex Oncology Drug Candidate TTX101 Receives FDA Orphan Drug Designation
October 20, 2023
- Nearly 80% of Patients with Moderate-to-Severe Atopic Dermatitis Maintained Clear or Almost Clear Skin with Lilly's Lebrikizumab Monthly Maintenance Dosing at Two Years
- FDA Clears Application to Initiate Phase 1 Clinical Study of oral Immunotherapy for the Treatment of Rheumatoid Arthritis
- Kisqali NATALEE analysis reinforces consistent reduction in risk of recurrence across key subgroups of patients with early breast cancer
- Journey Medical Corporation Announces Data from Bioavailability Study of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) vs. Solodyn® (Minocycline Hydrochloride Extended-Release Tablets, 105 mg)
- Amgen Presents New Tarlatamab Data In Small Cell Lung Cancer
October 21, 2023
October 23, 2023
- Datopotamab Deruxtecan Significantly Extended Progression-Free Survival vs. Chemotherapy in Patients with HR-Positive, HER2-Low or Negative Breast Cancer in TROPION-Breast01 Phase III Trial
- Landmark Phase 3 MARIPOSA Study Shows RYBREVANT® (amivantamab-vmjw) Plus Lazertinib Resulted in 30 Percent Reduction in Risk of Disease Progression or Death Compared to Osimertinib in Patients with EGFR-Mutated Non-Small Cell Lung Cancer
- Phase 3 MARIPOSA-2 Study Shows RYBREVANT® (amivantamab-vmjw) Plus Chemotherapy Given with or without Lazertinib Reduced Risk of Disease Progression or Death by 56 and 52 Percent Respectively in Patients with EGFR-Mutated Non-Small Cell Lung Cancer who Progressed on or after Osimertinib
- Datopotamab Deruxtecan Improved Progression-Free Survival vs. Chemotherapy in Patients with Previously Treated Non-Small Cell Lung Cancer in TROPION-Lung01 Phase III Trial
October 24, 2023
- Bristol Myers Squibb Announces U.S. FDA Breakthrough Therapy Designation for Investigational LPA1 Antagonist for Progressive Pulmonary Fibrosis
- Allergan Aesthetics Announces Positive Topline Results from Two Pivotal Phase 3 Studies of TrenibotulinumtoxinE (BoNT/E) for the Treatment of Glabellar Lines
- Moderna Announces First Participant Dosed in Phase 3 Study of mRNA-1083, a Combination Vaccine Against Influenza and COVID-19
October 25, 2023
October 26, 2023
- A large international study of migraine reveals new biological pathways for treatment
- Altimmune Granted Fast Track Designation By FDA For Pemvidutide For The Treatment Of Non-Alcoholic Steatohepatitis (NASH)
- Pfizer and BioNTech Announce Positive Topline Data for mRNA-based Combination Vaccine Program Against Influenza and COVID-19
- Oncternal Therapeutics Announces FDA Granted Fast Track Designation for ONCT-534 for the Treatment of Metastatic Castration-Resistant Prostate Cancer
October 30, 2023
- Novartis Investigational Atrasentan Phase III Study Demonstrates Clinically Meaningful and Highly Statistically Significant Proteinuria Reduction in Patients with IgA Nephropathy (IgAN)
- Robust Weight Loss Efficacy, Multiple Metabolic Benefits and Favorable Safety Profile of Higher Dose 9 mg Mazdutide Phase 2 Study for Obesity
- Deciphera Pharmaceuticals Announces Positive Top-line Results from MOTION Pivotal Phase 3 Study of Vimseltinib in Patients with Tenosynovial Giant Cell Tumor (TGCT) and Updated Results from Phase 1/2 Study of Vimseltinib in TGCT
- Reviva Announces Positive Topline Results from Global Pivotal Phase 3 RECOVER Trial of Brilaroxazine in Schizophrenia
- Pfizer's COVID-19 Oral Antiviral Treatment Transitioning from Government Distribution
- SELLAS Life Sciences Receives Fast Track Designation from FDA for SLS009 for Treatment of Relapsed/Refractory Peripheral T-cell Lymphomas
October 31, 2023
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