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.

Cellusion Receives U.S. FDA Orphan Drug Designation for CLS001
TOKYO, December 22, 2023--(BUSINESS WIRE)--Cellusion Inc. (CEO: Shin Hatou, M.D. Ph.D., " Cellusion " ), a deep tech start-up developing a novel cell therapy, announced that the U.S. Food and Drug Administration ( " FDA " ) has granted Orphan Drug... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 22, 2023 Category: Pharmaceuticals Source Type: clinical trials

FDA approves initiation of Phase II clinical trial of MTX652 in Acute Kidney Injury
CAMBRIDGE, England, Dec. 14, 2023. Mission Therapeutics ( " Mission " or the " Company " ), a clinical-stage biotech developing first-in-class therapeutics targeting mitophagy, today announces that the US Food and Drug Administration (FDA) has approved... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 15, 2023 Category: Pharmaceuticals Source Type: clinical trials

COA-APTIC Cognitive Interview Study of Caregiver and Clinician Assessment of Acute Pain in Infants and Young Children
Conditions: Acute Pain Interventions: Other: cognitive interview Sponsors: Duke University; Food and Drug Administration (FDA) Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 11, 2023 Category: Research Source Type: clinical trials

COVID-19 Pharmacotherapy Effectiveness in the VA Healthcare System
Conditions: COVID-19, SARS-CoV-2 Infection; COVID-19, SARS-CoV-2 Infection, RSV, Influenza Sponsors: VA Office of Research and Development; Department of Health and Human Services; Food and Drug Administration (FDA) Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 7, 2023 Category: Research Source Type: clinical trials

Johnson & Johnson ’s Investigational TAR-200 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of High-Risk Non-Muscle-Invasive Bladder Cancer
RARITAN, N.J., Dec. 4, 2023– Johnson& Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted TAR-200 Breakthrough Therapy Designation (BTD) for the potential future treatment of patients with Bacillus... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 4, 2023 Category: Pharmaceuticals Source Type: clinical trials

FDA Approval for Phase II Study of Silmitasertib in Patients with Community-Acquired Pneumonia Associated with Viral Infection
TAIPEI, Nov. 21, 2023. Senhwa Biosciences, Inc., a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, announced today that U.S. Food and Drug Administration has approved its Phase... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - November 22, 2023 Category: Pharmaceuticals Source Type: clinical trials

Bayer Provides Update on Voluntary Withdrawal of Aliqopa (copanlisib)
WHIPPANY, N.J., November 13, 2023--(BUSINESS WIRE)--Bayer today announced that, following discussions with the U.S. Food and Drug Administration (FDA), it will work with the FDA on a voluntary withdrawal of the Aliqopa (copanlisib) U.S. New Drug... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - November 13, 2023 Category: Pharmaceuticals Source Type: clinical trials

FDA Approves Zepbound for Chronic Weight Management, a New Treatment of Obesity or Overweight with Weight-Related Medical Problems
INDIANAPOLIS, Nov. 8, 2023. The U.S. Food and Drug Administration (FDA) approved Eli Lilly and Company ' s (NYSE: LLY) Zepbound™ (tirzepatide) injection, the first and only obesity treatment of its kind that activates both GIP (glucose-dependent... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - November 9, 2023 Category: Pharmaceuticals Source Type: clinical trials

Oncternal Therapeutics Announces FDA Granted Fast Track Designation for ONCT-534 for the Treatment of Metastatic Castration-Resistant Prostate Cancer
SAN DIEGO, Oct. 26, 2023 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced that the U.S. Food and Drug Administration... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 26, 2023 Category: Pharmaceuticals Source Type: clinical trials

Bristol Myers Squibb Announces U.S. FDA Breakthrough Therapy Designation for Investigational LPA1 Antagonist for Progressive Pulmonary Fibrosis
PRINCETON, N.J.--(BUSINESS WIRE) Oct 24, 2023 -- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for BMS-986278, a potential first-in-class, oral,... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 24, 2023 Category: Pharmaceuticals Source Type: clinical trials

FDA Clears Application to Initiate Phase 1 Clinical Study of oral Immunotherapy for the Treatment of Rheumatoid Arthritis
ROCKVILLE, Md., Oct. 19, 2023. - Rise Therapeutics, a biotechnology company engaged in developing novel oral immunotherapeutics, today announced that the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND)... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 20, 2023 Category: Pharmaceuticals Source Type: clinical trials

FDA Grants Fast Track Designation to ANPD001, Autologous Investigational Cell Therapy for the Treatment of Parkinson's Disease
SAN DIEGO, Oct. 19, 2023 /PRNewswire/ -- Aspen Neuroscience today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for ANPD001 for the treatment of Parkinson ' s disease (PD) to improve motor function.... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 19, 2023 Category: Pharmaceuticals Source Type: clinical trials

Diakonos Oncology Awarded FDA Fast Track Designation for Innovative Dendritic Cell Vaccine for Glioblastoma
HOUSTON--(BUSINESS WIRE) Oct 17, 2023 -- Diakonos Oncology Corporation (“Diakonos”), a clinical stage immuno-oncology company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 17, 2023 Category: Pharmaceuticals Source Type: clinical trials

MimiVax Granted Fast Track Designation from FDA for SurVaxM for Newly Diagnosed Glioblastoma
Buffalo, NY. October 12, 2023– MimiVax, Inc., a biotechnology company focused on the development of glioblastoma vaccine therapy, announced today that the United States Food and Drug Administration (FDA) has granted Fast Track... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 12, 2023 Category: Pharmaceuticals Source Type: clinical trials

South Rampart Pharma Receives U.S. FDA Fast Track Designation for SRP-001 for Acute Pain
NEW ORLEANS, Oct. 12, 2023 . South Rampart Pharma, Inc. ( " South Rampart " or the " Company " ), a clinical-stage biopharmaceutical company targeting the safer treatment of pain, today announced that the U.S. Food and Drug Administration (FDA) has... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 12, 2023 Category: Pharmaceuticals Source Type: clinical trials