Clinical Trial News Archive - May 2023
May 1, 2023
- U.S. Food & Drug Administration Issues Complete Response Letter for TransCon™ PTH in Hypoparathyroidism
- "Eat, Sleep, Console" Reduces Hospital Stay and Need for Medication Among Opioid-Exposed Infants
- Up to 73% of Atopic Dermatitis Patients Taking Lilly's Lebrikizumab Had Improved or Cleared Skin on Face or Hands in New Analysis
May 3, 2023
May 4, 2023
- Veru Reaches Agreement with FDA on Confirmatory Phase 3 Clinical Trial for Sabizabulin Treatment of Hospitalized COVID-19 Adult Patients at High Risk for ARDS
- ABM Announces First Patient Dosed in Phase I Clinical Trial of MEK Inhibitor for Solid Tumor
- Young Men at Highest Risk of Schizophrenia Linked with Cannabis Use Disorder
May 5, 2023
- FibroGen Announces Results for MATTERHORN, a Phase 3 Clinical Study of Roxadustat for the Treatment of Anemia in Patients with Myelodysplastic Syndromes (MDS)
- Phase 2 Trial Results for Antroquinonol as 1st Line Treatment for Stage 4 Metastatic Pancreatic Cancer
May 9, 2023
- Synlogic Receives Orphan Drug Designation from FDA for SYNB1934 for Treatment of Phenylketonuria
- Lilly Discloses First-in-Class, Interim Phase 2 Data in Pediatric Patients and New Analysis from Phase 3 Program in Adult Patients for Mirikizumab in Ulcerative Colitis
- Theravance Biopharma, Inc. Announces Orphan Drug Designation Granted to Ampreloxetine for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Patients with Multiple System Atrophy
May 10, 2023
May 11, 2023
- Abeona Therapeutics Announces Additional Phase 3 VIITAL™ Study Results for EB-101 Presented at the International Societies for Investigative Dermatology 2023 Meeting
- Results from Pivotal Phase 3 ATTACK Trial of Investigational Sulbactam-Durlobactam for Treatment of Serious Infections Caused by Acinetobacter Published in The Lancet Infectious Diseases
- Kintor Pharma Announces Successful Completion of Phase II Clinical Trial of KX-826 for Treatment of Androgenetic Alopecia in the US
May 12, 2023
- Sarepta Therapeutics Announces Positive Vote from U.S. FDA Advisory Committee Meeting for SRP-9001 Gene Therapy to Treat Duchenne Muscular Dystrophy
- Revive Therapeutics Provides Update of Phase 3 Clinical Study for Bucillamine in the Treatment of COVID-19
May 15, 2023
- First-In-Human Trial of Oral Drug to Remove Radioactive Contamination Begins
- Acesion Pharma Announces Positive Pre-Clinical Data for AP31969
- Clinical Trial of mRNA Universal Influenza Vaccine Candidate Begins
May 16, 2023
- Genentech’s BTK Inhibitor Fenebrutinib Significantly Reduced Brain Lesions in People With Relapsing Forms of Multiple Sclerosis
- Positive Topline Clinical Results Support Streamlined Development Pathway for LPCN 1154, Lipocine's Oral Candidate for Rapid Relief of Depression
- NIH Study Finds High Rates of Persistent Chronic Pain Among U.S. Adults
May 17, 2023
- PTC Therapeutics Announces APHENITY Trial Achieved Primary Endpoint with Sepiapterin in PKU Patients
May 18, 2023
- FDA Advisory Committee Votes in Support of Approval for Pfizer’s Vaccine Candidate to Help Prevent RSV in Infants Through Maternal Immunization
- Galera Announces FDA Orphan Drug Designation Granted to Rucosopasem for Pancreatic Cancer
- Lilly's peresolimab Phase 2a rheumatoid arthritis trial published in The New England Journal of Medicine
May 19, 2023
May 22, 2023
May 23, 2023
- Antengene Announces Claudin 18.2 Antibody-Drug Conjugate ATG-022 Granted Orphan Drug Designations by the U.S. FDA for the Treatment of Gastric and Pancreatic Cancers
- Allos Pharma Inc. Receives FDA Guidance for the Design of a Phase 3 Trial to Support a New Drug Application for Treatment of Fragile X Syndrome
- Lupus Research Alliance and its Clinical Research Affiliate Lupus Therapeutics Launch the Lupus Landmark Study to Accelerate Personalized Treatments in Lupus
May 24, 2023
- Sarepta Therapeutics Announces Update on Regulatory Review of SRP-9001
- Altamira Therapeutics Reports Positive Top-Line Data from Bentrio Clinical Trial in Seasonal Allergic Rhinitis
May 25, 2023
- Psilera Unveils Novel, Non-Hallucinogenic Psilocybin Derivative PSIL-006 As Lead Clinical Candidate
- Milvexian Granted U.S. FDA Fast Track Designation for All Three Indications Under Evaluation in Phase 3 Librexia Program: Ischemic Stroke, Acute Coronary Syndrome and Atrial Fibrillation
- Fianlimab (LAG-3 inhibitor) Combined with Libtayo® (cemiplimab) Shows Clinically Meaningful and Durable Tumor Responses Across Key Advanced Melanoma Patient Populations
- Updated Linvoseltamab (BCMAxCD3) Data from Pivotal Trial Demonstrates Early, Deep and Durable Responses in Patients with Heavily Pre-treated Multiple Myeloma
May 26, 2023
May 29, 2023
May 30, 2023
- First Subject Dosed in a Phase 1 Study of JCXH-105, a Self-Replicating RNA-Based Vaccine Developed for the Prevention of Shingles
- Research and Pipeline Pfizer Announces Positive Marstacimab Results from Pivotal Phase 3 Hemophilia A and B Trial
May 31, 2023
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