Sibeprenlimab Receives U.S. FDA Breakthrough Therapy Designation for the Treatment of Immunoglobulin A Nephropathy
PRINCETON, N.J.; TOKYO, JAPAN; WALTHAM, MA. February 16, 2024– Otsuka Pharmaceutical Development& Commercialization, Inc., (OPDC); Otsuka Pharmaceutical, Co. Ltd. (Otsuka); and Visterra, Inc., an Otsuka group company announce that the... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 16, 2024 Category: Pharmaceuticals Source Type: clinical trials
Cardiol Therapeutics Granted Orphan Drug Designation for its Lead Drug Candidate CardiolRx for the Treatment of Pericarditis
Toronto, ON– February 15, 2024– Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) (“Cardiol” or the“Company”), a clinical-stage life sciences company focused on the research and clinical development of... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 15, 2024 Category: Pharmaceuticals Source Type: clinical trials
Applied Therapeutics Announces Positive Results from 12-month Interim Analysis of Govorestat (AT-007) in the Ongoing INSPIRE Phase 3 Trial in Sorbitol Dehydrogenase (SORD) Deficiency
NEW YORK, Feb. 15, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 15, 2024 Category: Pharmaceuticals Source Type: clinical trials
Diamyd Medical Receives U.S. FDA Fast Track Designation for Diamyd (rhGAD65/alum)
February 15, 2024 Diamyd Medical announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Diamyd® (rhGAD65/alum) that is being investigated to improve glycemic control in recently diagnosed stage 3... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 15, 2024 Category: Pharmaceuticals Source Type: clinical trials
Replicate Bioscience Announces Positive Initial Clinical Results for its Next Generation srRNA Technology
SAN DIEGO, Feb. 14, 2024. Replicate Bioscience, a clinical-stage company pioneering novel self-replicating RNA (srRNA) technology to expand applications of RNA vaccines and other treatments, today shared positive results from the Phase 1 trial of... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 14, 2024 Category: Pharmaceuticals Source Type: clinical trials
Edgewise Receives U.S. FDA Fast Track Designation for EDG-5506 for the Treatment of Duchenne Muscular Dystrophy
BOULDER, Colo.--(BUSINESS WIRE) February 13, 2024 -- Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 13, 2024 Category: Pharmaceuticals Source Type: clinical trials
KalVista Pharmaceuticals Reports Phase 3 KONFIDENT Trial Meets All Endpoints for Sebetralstat as First Oral On-demand Therapy for Hereditary Angioedema
CAMBRIDGE, Mass.& SALISBURY, England--(BUSINESS WIRE)--Feb. 13, 2024-- KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 13, 2024 Category: Pharmaceuticals Source Type: clinical trials
Potassium Correction for RAAS Optimization in Chronic Kidney Disease
Conditions: Chronic Kidney Diseases; Hyperkalemia; Hypertension Interventions: Drug: Patiromer 8400 MG [Veltassa]; Drug: Placebo Sponsors: University Medical Center Groningen; Amsterdam University Medical Center; Medical Centre Leeuwarden; Isala; Vifor Pharma, Inc.; Dutch Kidney Foundation; Health Holland Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 13, 2024 Category: Research Source Type: clinical trials
Summary Toggle Krystal Biotech Receives FDA Fast Track Designation for Inhaled Oncology Candidate KB707 to Treat Solid Tumors of the Lung
PITTSBURGH, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the“Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 13, 2024 Category: Pharmaceuticals Source Type: clinical trials
Kintara Therapeutics Announces Initiation of REM-001 Clinical Trial for the Treatment of Cutaneous Metastatic Breast Cancer
SAN DIEGO, Feb. 12, 2024. Kintara Therapeutics, Inc. ( " Kintara " or the " Company " ), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced the initiation of a REM-001 15-patient clinical trial... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 13, 2024 Category: Pharmaceuticals Source Type: clinical trials
BioXcel Therapeutics Receives FDA Fast Track Designation for BXCL701 for Treatment of Small Cell Neuroendocrine Prostate Cancer (SCNC)
NEW HAVEN, Conn., Feb. 12, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 12, 2024 Category: Pharmaceuticals Source Type: clinical trials
Visualizing Brain Proteinopathies Using [F-18]Flornaptitril-PET in the Prediction of Clinical Progression of Mild Cognitive Impairment With Either Suspected Chronic Traumatic Encephalopathy or Alzheimer's Disease
Conditions: Alzheimer Disease; Chronic Traumatic Encephalopathy Interventions: Drug: [F-18]Flornaptitril Sponsors: CereMark Pharma, LLC Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 12, 2024 Category: Research Source Type: clinical trials
Nuvalent Initiates the Phase 2 Portion of ALKOVE-1 Clinical Trial for Patients with ALK-Positive NSCLC and other Solid Tumors
CAMBRIDGE, Mass., Feb. 12, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 12, 2024 Category: Pharmaceuticals Source Type: clinical trials
GSK Receives US FDA Fast Track Designation for Bepirovirsen in Chronic Hepatitis B
London, UK 12 February 2024 -- GSK plc (LSE/NYSE: GSK) announced today that the US Food and Drug Administration (FDA) has granted Fast Track designation for bepirovirsen, an investigational antisense oligonucleotide (ASO) for the treatment of... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 12, 2024 Category: Pharmaceuticals Source Type: clinical trials
Otsuka Announces Phase 3 Topline Results of AVP-786 in the Treatment of Agitation Associated With Dementia Due to Alzheimer ’s Disease
PRINCETON, N.J. and TOKYO, JAPAN February 12, 2024– Otsuka Pharmaceutical Development& Commercialization, Inc., (OPDC) and our parent company Otsuka Pharmaceutical, Co. Ltd. (Otsuka) announce topline results of the phase 3 clinical trial... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 12, 2024 Category: Pharmaceuticals Source Type: clinical trials
