Drugs.com - Clinical Trials Clinical trial news from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals.
- TLX101-CDx (Pixclara) Granted FDA Fast Track Designationon April 16, 2024 at 2:04 am
Melbourne (Australia) | 16 April 2024 -- Telix today announces that the United States (U.S.) Food and Drug Administration (FDA) has granted Fast Track designation1 for the Company’s investigational glioma imaging product, TLX101-CDx...
- The United States FDA Awards Orphan Drug Designation (ODD) to NM5072 for Treating Paroxysmal Nocturnal Hemoglobinuria (PNH)on April 15, 2024 at 7:04 pm
CLEVELAND, April 15, 2024 (GLOBE NEWSWIRE) -- NovelMed today announced that the Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to NM5072, an Alternative Pathway (AP) blocker anti-Properdin antibody, for the...
- PaxMedica Achieves Key Milestone in the Development of PAX-101 And Provides Update on Potential NDA Submissionon April 11, 2024 at 11:04 pm
TARRYTOWN, New York, April 11, 2024 – via IBN – PaxMedica, Inc. (NASDAQ:PXMD), a biopharmaceutical company focused on advancing treatments for neurological disorders, today announced the completed execution of its three pivotal...
- Study Reveals No Causal Link Between Neurodevelopmental Disorders and Acetaminophen Exposure Before Birthon April 11, 2024 at 3:04 am
April 11, 2024 -- Study reveals no causal link between neurodevelopmental disorders and acetaminophen exposure before birth. NIH-funded research in siblings finds previously reported connection is likely due to other underlying...
- AIM ImmunoTech Announces Positive Top-Line, Protocol-Planned Interim Report Data from the Study of Ampligen Combined with Pembrolizumab for the Treatment of Recurrent Ovarian Canceron April 10, 2024 at 11:04 pm
OCALA, Fla., April 10, 2024 — AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM”) today announced top-line interim data indicating that combining Ampligen (rintatolimod) with Keytruda (pembrolizumab) in the treatment of recurrent...
- Amylyx Pharmaceuticals Announces Interim Data From Ongoing Phase 2 HELIOS Clinical Trial Demonstrating Improvements in Pancreatic Function and Glycemic Control with AMX0035 in People with Wolfram Syndromeon April 10, 2024 at 4:04 am
CAMBRIDGE, Mass.--(BUSINESS WIRE) April 10, 2024 -- Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced interim data from the ongoing Phase 2 HELIOS clinical trial of AMX0035 (sodium...
- Cadrenal Therapeutics Receives FDA Orphan Drug Designation for Tecarfarin for Prevention of Thromboembolism and Thrombosis in Patients with LVADs, RVADs, Biventricular Assist Devices, and Total Artificial Heartson April 9, 2024 at 7:04 pm
PONTE VEDRA, Fla., April 9, 2024 — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage novel oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes,...
- NRx Pharmaceuticals Announces Data-Lock of Phase 2b/3 Trial of NRX-101 in Suicidal Treatment Resistant Bipolar Depressionon April 9, 2024 at 5:04 am
RADNOR, Pa., April 8, 2024. NRx Pharmaceuticals, Inc. ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that the Company has achieved data-lock in its Phase 2b/3 Suicidal Treatment Resistant Bipolar...
- Syros Receives Fast Track Designation from the FDA for Tamibarotene for the Treatment of Newly Diagnosed Unfit AML with RARA Gene Overexpressionon April 9, 2024 at 4:04 am
CAMBRIDGE, Mass.--(BUSINESS WIRE) April 09, 2024 -- Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company committed to advancing new standards of care for the frontline treatment of hematologic malignancies, today announced that the...
- YS Biopharma Announces Positive Interim Results of Pivotal Phase 3 Clinical Study of PIKA Rabies Vaccineon April 9, 2024 at 4:04 am
GAITHERSBURG, Md., April 9, 2024 /PRNewswire/ -- YS Biopharma Co., Ltd. (Nasdaq: YS) ("YS Biopharma" or the "Company"), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of...
- FDA Grants Breakthrough Therapy Designation to Sunvozertinib for the First-Line Treatment of Patients with advanced Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutationson April 7, 2024 at 10:04 pm
SHANGHAI, April 7, 2024 /PRNewswire/ -- Dizal (688192.SH) today announced that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Therapy Designation (BTD) to its sunvozertinib as the first-line treatment for patients with...
- Ionis Presents Positive Results from Phase 3 Balance Study of Olezarsen for Familial Chylomicronemia Syndromeon April 7, 2024 at 8:04 pm
CARLSBAD, Calif., April 7, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced full results from the Phase 3 Balance study of Ionis' lead independent investigational medicine, olezarsen, for the treatment of adults with...
- Linvoseltamab Pivotal Data Presented at AACR Reinforce High Response Rate that Deepens Over Time in Patients with Heavily Pre-Treated Multiple Myelomaon April 7, 2024 at 2:04 am
TARRYTOWN, N.Y., April 07, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the oral plenary session presentation of positive pivotal data from the Phase 1/2 LINKER-MM1 trial of linvoseltamab in patients with...
- Arrowhead Pharmaceuticals Announces New Phase 2 Data of Plozasiran Published in JAMA Cardiology and Presented at American College of Cardiology 73rd Annual Scientific Session & Expoon April 7, 2024 at 2:04 am
PASADENA, Calif.–(BUSINESS WIRE)–Apr. 7, 2024– Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today presented final data from the double-blind treatment period of its Phase 2 SHASTA-2 study of investigational plozasiran (formerly...
- Bristol Myers Squibb Presents New Interim Long-Term Efficacy Data from the EMERGENT-4 Trial Evaluating KarXT in Schizophrenia at the 2024 Annual Congress of the Schizophrenia International Research Societyon April 6, 2024 at 1:04 am
PRINCETON, N.J.--(BUSINESS WIRE) April 6, 2024 -- Bristol Myers Squibb (NYSE: BMY) today announced new interim results from the Phase 3 EMERGENT-4 open-label extension trial evaluating the long-term efficacy, safety and tolerability of KarXT...
- Bristol Myers Squibb Presents New Pooled Interim Long-Term Safety and Metabolic Outcomes Data from the EMERGENT Program Evaluating KarXT in Schizophrenia at the 2024 Annual Congress of the Schizophrenia International Research Societyon April 6, 2024 at 1:04 am
PRINCETON, N.J.--(BUSINESS WIRE) April 6, 2024 -- Bristol Myers Squibb (NYSE: BMY) today announced interim long-term safety, tolerability and metabolic outcomes data from its Phase 3 EMERGENT program evaluating KarXT (xanomeline-trospium) in adults...
- Amylyx Pharmaceuticals Announces Formal Intention to Remove Relyvrio from the Marketon April 4, 2024 at 11:04 pm
CAMBRIDGE, Mass.--(BUSINESS WIRE) April 04, 2024 -- Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced the Company has started a process with the U.S. Food and Drug Administration (FDA)...
- EILEAN THERAPEUTICS RECEIVES CLEARANCE TO INITIATE R/R AML TRIAL WITH LOMONITINIB, A SELECTIVE PAN-FLT3/IRAK4 INHIBITORon April 4, 2024 at 8:04 pm
DOVER, Del., April 4, 2024. Eilean Therapeutics LLC, a biopharmaceutical company dedicated to discovering and developing best-in-class and first-in-class small molecule inhibitors to target escape mutations in hematologic and solid malignancies, is...
- First-Patient Dosed in Phase 2 Clinical Study Evaluating NBI-1070770 in Adults with Major Depressive Disorderon April 4, 2024 at 3:04 am
SAN DIEGO, April 3, 2024. Neurocrine Biosciences, Inc. today announced that the first patient has been randomized for its Phase 2 clinical study to evaluate the efficacy, safety, and tolerability of investigational compound NBI-1070770 in adults...
- Merck Initiates Phase 3 Clinical Trial of MK-1084, an Investigational Oral KRAS G12C Inhibitor, in Combination with Keytruda (pembrolizumab) for First-Line Treatment of Certain Patients With Metastatic Non-Small Cell Lung Canceron April 4, 2024 at 1:04 am
RAHWAY, N.J.--(BUSINESS WIRE) April 4, 2024 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced it has initiated a Phase 3 clinical trial evaluating MK-1084, an investigational oral selective KRAS G12C...
