Clinical Trial News Archive - December 2024
December 2, 2024
December 3, 2024
- FDA Grants Fast Track Designation to CRB-701 for the Treatment of Relapsed or Refractory Metastatic Cervical Cancer
- Lantern Pharma's Investigational Drug-Candidate, LP-184, Receives Second Fast Track Designation from FDA for Treatment of Triple Negative Breast Cancer (TNBC)
- FDA Grants Breakthrough Therapy Designation to Sacituzumab Tirumotecan (sac-TMT) for the Treatment of Certain Patients With Previously Treated Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer With EGFR Mutations
December 4, 2024
- Syros Announces Topline Data from SELECT-MDS-1 Phase 3 Trial of Tamibarotene in Higher-Risk Myelodysplastic Syndrome with RARA Gene Overexpression
- Amylyx Pharmaceuticals Announces Pivotal Phase 3 LUCIDITY Trial Design for GLP-1 Receptor Antagonist (Avexitide) in Post-Bariatric Hypoglycemia
- FDA Grants Revascor (Rexlemestrocel-L) Regenerative Medicine Advanced Therapy (RMAT) Designation in Children with Congenital Heart Disease
- Phanes Therapeutics’ PT217 Granted Fast Track Designation by the FDA for NEPC
December 5, 2024
December 6, 2024
- BioAge Labs Announces Discontinuation of STRIDES Phase 2 Clinical Trial Evaluating Azelaprag in Combination with Tirzepatide for the Treatment of Obesity
- Xenon Showcases New Long-Term Azetukalner Data from X-TOLE OLE Study
December 7, 2024
- Rilzabrutinib Demonstrated Significant Patient Benefit in the First Positive Phase 3 Study of a BTK Inhibitor in ITP
- Novel Combination of Pozelimab and Cemdisiran (Poze-Cemdi) Achieved Greater Control of Intravascular Hemolysis in Patients with Paroxysmal Nocturnal Hemoglobinuria Compared to Ravulizumab
- Phase 2 Data From the Ongoing Hibiscus Study Shows Promise That Investigational Etavopivat Could Reduce the Incidence of Vaso-occlusive Crises in People With Sickle Cell Disease
December 8, 2024
December 9, 2024
- Datopotamab Deruxtecan Granted Breakthrough Therapy Designation in US for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer
- Odronextamab ASH Presentations Underscore Impressive Potential in Earlier Lines of Treatment and Additional Types of Lymphoma
- Chimerix to Submit Dordaviprone for Accelerated Approval to U.S. FDA for Patients with Recurrent H3 K27M-Mutant Diffuse Glioma Before Year-End
December 10, 2024
- uniQure Announces Alignment with FDA on Key Elements of Accelerated Approval Pathway for AMT-130 in Huntington’s Disease
- Zealand Pharma Announces First Participant Enrolled in Phase 2b ZUPREME-1 Trial of Petrelintide in People with Overweight or Obesity
- Novavax Initiates Phase 3 Trial for COVID-19-Influenza Combination and Stand-Alone Influenza
- Acelyrin, Inc. Announces Topline Results From Phase 2b/3 Study of Izokibep for the Treatment of Uveitis
- NIH Study Finds Tecovirimat Was Safe but Did Not Improve Mpox Resolution or Pain
December 11, 2024
- Corcept Announces Results From Phase 2 Study of Dazucorilant in Patients With Amyotrophic Lateral Sclerosis (ALS)
- Lilly's Imlunestrant, an Oral SERD, Significantly Improved Progression-Free Survival as Monotherapy and in Combination with Verzenio® (abemaciclib) in Patients with ER+, HER2- Advanced Breast Cancer
December 12, 2024
- Pilatus Biosciences Inc. Receives Orphan Drug Designation from FDA for PLT012 in Treatment of Liver and Intrahepatic Bile Duct Cancer
- Repare Therapeutics Announces Positive Results of the Lunresertib and Camonsertib Combination from the MYTHIC Phase 1 Gynecologic Expansion Clinical Trial
- Vir Biotechnology Receives FDA Breakthrough Therapy Designation and EMA PRIME Designation for Tobevibart and Elebsiran in Chronic Hepatitis Delta
December 13, 2024
- Tolebrutinib Designated Breakthrough Therapy by the FDA for Non-Relapsing Secondary Progressive Multiple Sclerosis
- FDA Revokes EUA for Evusheld (tixagevimab co-packaged with cilgavimab) for the Treatment of COVID-19
- FDA Revokes EUA for REGEN-COV (casirivimab and imdevimab) for the Treatment of COVID-19
- FDA Revokes EUA for Sotrovimab for the Treatment of COVID-19
- FDA Revokes Emergency Use Authorization (EUA) for Bebtelovimab for the Treatment of COVID-19
December 16, 2024
- Findings from Minzasolmin Proof-of-Concept ORCHESTRA Study Shape Next Steps in UCB Parkinson’s Research Program
- Merck Provides Update on KeyVibe and KEYFORM Clinical Development Programs Evaluating Investigational Vibostolimab and Favezelimab Fixed-Dose Combinations with Pembrolizumab
December 17, 2024
- FDA Grants Fast Track Designation to Lipocine for LPCN 1148 as a Treatment for Sarcopenia in Patients with Decompensated Cirrhosis
- Reported Use of Most Drugs Among Adolescents Remained Low in 2024
December 18, 2024
- Pila Pharma Announces XEN-D0501 Preclinical Proof-of-Concept Achieved In Cardiovascular Disease Study
- Genentech’s Phase IIb Study of Prasinezumab Missed Primary Endpoint, but Suggests Possible Benefit in Early-Stage Parkinson’s Disease
December 19, 2024
- Sapience Therapeutics Receives FDA Orphan Drug Designation for ST316, a First-in-Class β-catenin Antagonist, for the Treatment of Familial Adenomatous Polyposis (FAP)
- Nurix Therapeutics Receives U.S. FDA Fast Track Designation for NX-5948 for the Treatment of Relapsed or Refractory Waldenstrom’s Macroglobulinemia
- Vertex Announces Results From Phase 2 Study of Suzetrigine for the Treatment of Painful Lumbosacral Radiculopathy
- LimmaTech Awarded FDA Fast Track Designation for Vaccine Candidate Against Staphylococcus aureus
December 20, 2024
December 30, 2024
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