Food and Drug Administration (FDA) Clinical Trials This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

The United States FDA Awards Orphan Drug Designation (ODD) to NM5072 for Treating Paroxysmal Nocturnal Hemoglobinuria (PNH)
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... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 15, 2024 Category: Pharmaceuticals Source Type: clinical trials

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 Mutations
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... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 7, 2024 Category: Pharmaceuticals Source Type: clinical trials

Amylyx Pharmaceuticals Announces Formal Intention to Remove Relyvrio from the Market
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)... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 4, 2024 Category: Pharmaceuticals Source Type: clinical trials

Otsuka and Click Therapeutics Announce the U.S. Food and Drug Administration (FDA) Clearance of Rejoyn, the First Prescription Digital Therapeutic Authorized for the Adjunctive Treatment of Major Depressive Disorder (MDD) Symptoms
PRINCETON, N.J. and NEW YORK, N.Y. (April 1, 2024)– Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and Click Therapeutics, Inc., (Click) announce that the U.S. Food and Drug Administration (FDA) has cleared Rejoyn™ (developed as CT-152), the... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 1, 2024 Category: Pharmaceuticals Source Type: clinical trials

Johnson & Johnson's Nipocalimab Granted U.S. FDA Fast Track Designation to Reduce the Risk of Fetal Neonatal Alloimmune Thrombocytopenia (FNAIT) in Alloimmunized Pregnant Adults
SPRING HOUSE, Pa. March 26, 2024– Johnson& Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) for nipocalimab to reduce the risk of FNAIT in alloimmunizeda pregnant adults... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - March 26, 2024 Category: Pharmaceuticals Source Type: clinical trials

Pharmacokinetics of Intravenous and Intranasal Formulations of Naloxone in Healthy Volunteers.
Conditions: Healthy Interventions: Drug: Intravenous naloxone; Drug: Intranasal naloxone Sponsors: Parc de Salut Mar; Food and Drug Administration (FDA) Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - March 12, 2024 Category: Research Source Type: clinical trials

The scientific rationale and study protocol for the DPP3, Angiotensin II, and Renin Kinetics in Sepsis (DARK-Sepsis) randomized controlled trial: serum biomarkers to predict response to angiotensin II versus standard-of-care vasopressor therapy in the treatment of septic shock
DiscussionWith an armamentarium of mechanistically distinct vasopressor agents now available, sub-phenotyping patients using biomarkers has the potential to improve septic shock outcomes by enabling treatment of the correct patient with the correct vasopressor at the correct time. However, this approach requires validation in a large definitive multicenter trial. The data generated through the DARK-Sepsis study will prove crucial to the optimal design and patient enrichment of such a pivotal trial.Trial registrationClinicalTrials.gov NCT05824767. Registered on April 24, 2023. (Source: Trials)
Source: Trials - March 12, 2024 Category: Research Source Type: clinical trials

Viatris and Mapi Pharma Statement Regarding New Drug Application for GA Depot
March 11, 2024 -- Viatris Inc. has been informed that Mapi Pharma Ltd. has received a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for GA Depot 40 mg from the U.S. Food and Drug Administration (FDA). The Companies are... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - March 11, 2024 Category: Pharmaceuticals Source Type: clinical trials

U.S. Food and Drug Administration to Convene Advisory Committee Meeting to Discuss the TRAILBLAZER-ALZ 2 Study of Donanemab
INDIANAPOLIS, March 8, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) expects to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS)... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - March 8, 2024 Category: Pharmaceuticals Source Type: clinical trials

Verastem Oncology Receives Orphan Drug Designation from FDA for Avutometinib Alone or in Combination With Defactinib in Recurrent Low-Grade Serous Ovarian Cancer
BOSTON--(BUSINESS WIRE)--Mar. 5, 2024-- Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - March 5, 2024 Category: Pharmaceuticals Source Type: clinical trials

Implementing the COMFORT Guidelines for Postpartum Pain Management
Conditions: Postpartum Pain; Opioid Stewardship; Maternity Care; Obstetric Care Interventions: Behavioral: REP; Behavioral: Facillitation Sponsors: University of Michigan; Food and Drug Administration (FDA) Active, not recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 29, 2024 Category: Research Source Type: clinical trials

Lutris Pharma Receives FDA Orphan Drug Designation for LUT014 for the Treatment of EGFRI-Induced Acneiform Rash
Feb. 28, 2024 -- Lutris Pharma, a clinical stage biopharmaceutical company focused on improving anti-cancer therapies by reducing dose limiting side effects, today announced that the U.S. Food and Drug Administration ' s... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 28, 2024 Category: Pharmaceuticals Source Type: clinical trials

Bayer Receives U.S. FDA Breakthrough Therapy Designation for BAY 2927088 for Non-Small Cell Lung Cancer Harboring HER2 Activating Mutations
Berlin, Germany, February 26, 2024– Bayer announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for BAY 2927088 for the treatment of adult patients with unresectable or metastatic... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 26, 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

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