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.

Astellas Receives U.S. FDA Fast Track Designation for ASP5354, an Investigational Near-Infrared Fluorescence Imaging Agent
TOKYO, Oct. 28, 2020 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., " Astellas " ) announced today that the United States ( " U.S. " ) Food and Drug Administration (FDA) has granted... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 28, 2020 Category: Pharmaceuticals Source Type: clinical trials

FDA Grants Priority Review and EMA Accepts Regulatory Submission for Pfizer ’s Abrocitinib, an Oral Once-Daily JAK1 Inhibitor, for Patients 12 and Up with Moderate to Severe Atopic Dermatitis
NEW YORK--(BUSINESS WIRE) October 27, 2020 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) accepted for filing and granted Priority Review designation to the company’s New Drug Application (NDA) for... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 27, 2020 Category: Pharmaceuticals Source Type: clinical trials

Forte Biosciences, Inc. Announces the FDA Has Granted Fast Track Designation to FB-401 for the Treatment of Atopic Dermatitis
TORRANCE, Calif.--(BUSINESS WIRE) October 26, 2020 -- Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage 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 - October 26, 2020 Category: Pharmaceuticals Source Type: clinical trials

FDA Grants Fast Track Designation for ASP0367/MA-0211, a Selective PPAR δ Modulator being Developed for the Treatment of Primary Mitochondrial Myopathies
TOKYO, Oct. 20, 2020 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., " Astellas " ) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 20, 2020 Category: Pharmaceuticals Source Type: clinical trials

Xanthohumol microbiome and signature in healthy adults (the XMaS trial): a phase I triple-masked, placebo-controlled clinical trial
DiscussionThis phase I clinical trial of xanthohumol will assess safety and tolerability in healthy adults, collect extensive biomarker data for assessment of potential mechanism(s), and provide comparison data necessary for future phase II trials in chronic disease(s). The design and robustness of the planned safety and mechanistic evaluations planned provide a model for drug discovery pursuits from natural products.Trial registrationClinicalTrials.govNCT03735420. Registered on November 8, 2018 (Source: Trials)
Source: Trials - October 6, 2020 Category: Research Source Type: clinical trials

Oncternal Therapeutics Receives Rare Pediatric Disease Designation from U.S. Food and Drug Administration for TK216 for Treatment of Ewing Sarcoma
SAN DIEGO--(BUSINESS WIRE)--Oct. 6, 2020-- 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... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 6, 2020 Category: Pharmaceuticals Source Type: clinical trials

CTI BioPharma to Submit a New Drug Application (NDA) for the Accelerated Approval of Pacritinib for the Treatment of Myelofibrosis Patients with Severe Thrombocytopenia
SEATTLE, Sept. 29, 2020 /PRNewswire/ -- CTI BioPharma Corp. (Nasdaq: CTIC) today announced that following a recent Pre-NDA meeting with the U.S. Food and Drug Administration ( " FDA " or " the Agency " ), the Company has... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - September 29, 2020 Category: Pharmaceuticals Source Type: clinical trials

AbbVie Receives Orphan Drug and Fast Track Designations from the U.S. Food and Drug Administration for Elezanumab, an Investigational Monoclonal Antibody RGMa Inhibitor, for the Treatment of Spinal Cord Injury
NORTH CHICAGO, Ill., Sept. 28, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug and Fast Track designations for elezanumab (ABT-555), an investigational... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - September 28, 2020 Category: Pharmaceuticals Source Type: clinical trials

Gilead ’s Magrolimab, an Investigational Anti-CD47 Monoclonal Antibody, Receives FDA Breakthrough Therapy Designation for Treatment of Myelodysplastic Syndrome
FOSTER CITY, Calif.--(BUSINESS WIRE)--Sep. 15, 2020-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for magrolimab, a... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - September 21, 2020 Category: Pharmaceuticals Source Type: clinical trials

Pfizer and BioNTech Propose Expansion of Pivotal COVID-19 Vaccine Trial
NEW YORK& MAINZ, Germany--(BUSINESS WIRE) September 12, 2020 -- Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) announced today that they have submitted an amended protocol to the U.S. Food and Drug Administration to expand the... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - September 12, 2020 Category: Pharmaceuticals Source Type: clinical trials

FDA Grants Priority Review of Melflufen for Patients with Triple-Class Refractory Multiple Myeloma
STOCKHOLM— August 29, 2020— Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) today announces that the US Food and Drug Administration, FDA, has granted priority review for Oncopeptides´ New Drug Application... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - August 29, 2020 Category: Pharmaceuticals Source Type: clinical trials

Gilead ’s Investigational Antiviral Veklury (Remdesivir) Receives U.S. Food and Drug Administration Emergency Use Authorization for the Treatment of Patients With Moderate COVID-19
FOSTER CITY, Calif.--(BUSINESS WIRE)--Aug. 28, 2020-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) expanded the Emergency Use Authorization (EUA) enabling use of the... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - August 28, 2020 Category: Pharmaceuticals Source Type: clinical trials

US FDA Grants Rare Pediatric Disease Designation (RPDD) to Paxalisib for Diffuse Intrinsic Pontine Glioma (DIPG)
SYDNEY, Aug. 7, 2020 /PRNewswire/ -- Kazia Therapeutics Limited (ASX: KZA;NASDAQ: KZIA), an Australian oncology-focused biotechnology company, is pleased to announce that the United States Food and Drug Administration (FDA) has... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - August 7, 2020 Category: Pharmaceuticals Source Type: clinical trials

FDA Accepts Biogen ’s Aducanumab Biologics License Application for Alzheimer's Disease with Priority Review
CAMBRIDGE, Mass. and TOKYO, Aug. 07, 2020 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - August 7, 2020 Category: Pharmaceuticals Source Type: clinical trials

FDA Grants Fast Track Designation for BCX9930 in PNH
RESEARCH TRIANGLE PARK, N.C., Aug. 03, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its oral Factor D... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - August 3, 2020 Category: Pharmaceuticals Source Type: clinical trials