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
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
Johnson & Johnson ’s Nipocalimab Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of Individuals at High Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
Spring House, Pa. (February 9, 2024)– Johnson& Johnson today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for nipocalimab for the treatment of alloimmunizeda pregnant... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 9, 2024 Category: Pharmaceuticals Source Type: clinical trials
Orexa Announces First Patient Dosed in Phase 2 Trial in Post-Operative Patients
HERPEN, The Netherlands, Feb. 8, 2024. Orexa B.V., a Dutch life sciences company that is developing a new medicine that increases food intake and supports health in patients, announces that the first patient has been dosed in a Phase 2 clinical... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 9, 2024 Category: Pharmaceuticals Source Type: clinical trials
Beacon Therapeutics Announces Positive 12-Month Data from Phase 2 SKYLINE Trial of AGTC-501 in Patients with X-Linked Retinitis Pigmentosa
London, UK, Cambridge, MA, 08 February 2024– Beacon Therapeutics Holdings Limited (‘Beacon Therapeutics’ or‘the Company’), a leading ophthalmic gene therapy company with a mission to save and restore the vision of... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 8, 2024 Category: Pharmaceuticals Source Type: clinical trials
Corvus Pharmaceuticals Announces Orphan Drug Designation Granted to Soquelitinib for the Treatment of T Cell Lymphoma
BURLINGAME, Calif., Feb. 08, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 8, 2024 Category: Pharmaceuticals Source Type: clinical trials
