New England Journal of Medicine Publishes Positive Results of Cefepime-Taniborbactam from Phase 3 CERTAIN-1 Study of Patients with Complicated Urinary Tract Infection
Malvern, PA, Parsippany, NJ, and Florence, Italy– February 20, 2024– Venatorx Pharmaceuticals, Melinta Therapeutics LLC (“Melinta”), and Menarini Group today announced that The New England Journal of Medicine (NEJM)... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 20, 2024 Category: Pharmaceuticals Source Type: clinical trials
Treadwell Announces Ocifisertib, a First-in-Class PLK4 Inhibitor, has Received Orphan Designation from U.S. FDA for the Treatment of Acute Myeloid Leukemia
TORONTO& SAN FRANCISCO–(BUSINESS WIRE) February 20, 2024–Treadwell Therapeutics, a privately held clinical-stage biotechnology company pioneering and advancing novel first-in-class medicines for unmet needs in cancer, today... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 20, 2024 Category: Pharmaceuticals Source Type: clinical trials
Patient Enrollment Completed for Opvika Phase I/II Clinical Trial in the U.S
WUHAN, China and SAN DIEGO, Feb. 19, 2024. Neurophth Therapeutics, Inc. ( " Neurophth " ) announced today that the last patient has been enrolled in Phase I/II clinical trial of Opvika (Esonadogene Imvoparvovec) for the treatment of Leber hereditary... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 19, 2024 Category: Pharmaceuticals Source Type: clinical trials
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
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
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
