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.

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

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

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

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

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

Gilead Statement on Discontinuation of Phase 3 ENHANCE-3 Study of Magrolimab in AML
Foster City, Calif., February 7, 2024– Gilead Sciences, Inc. (Nasdaq: GILD) today announced it has discontinued the Phase 3 ENHANCE-3 study of magrolimab in acute myeloid leukemia (AML) and that the U.S. Food and Drug Administration (FDA)... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 7, 2024 Category: Pharmaceuticals Source Type: clinical trials

Biosyngen Announces FDA Fast Track Designation For BST02 In Treatment Of Liver Cancer
SINGAPORE, Feb. 1, 2024 /PRNewswire/ -- Biosyngen is proud to announce that its latest groundbreaking product, BST02, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of all types of... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 1, 2024 Category: Pharmaceuticals Source Type: clinical trials

Endogenex Receives IDE Approval to Initiate Pivotal Clinical Study
MINNEAPOLIS, Jan. 30, 2024. Endogenex, Inc., a clinical stage medical device company dedicated to improving outcomes in patients with Type 2 Diabetes (T2D), announced that the U.S. Food and Drug Administration (FDA) granted an Investigational Device... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 31, 2024 Category: Pharmaceuticals Source Type: clinical trials

Hoth Therapeutics Announces it Received FDA Approval to Expand HT-001 Clinical Trial to Treat Severely Ill Patients
NEW YORK, Jan. 18, 2024. Hoth Therapeutics, Inc., a patient-focused biopharmaceutical company, announced today that it has received U.S. Food and Drug Administration (FDA) clearance to implement a number of protocol amendments to its ongoing... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 18, 2024 Category: Pharmaceuticals Source Type: clinical trials

Pleco Therapeutics receives FDA Orphan Drug Designation for PTX-252
Nijmegen, The Netherlands– 16th January 2024– The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Pleco Therapeutics BV’s lead compound, PTX-252 for the treatment of Acute Myeloid Leukaemia (AML).... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 16, 2024 Category: Pharmaceuticals Source Type: clinical trials

FDA Approves Phase II Clinical Trial of Ropidoxuridine for Treatment of Patients with Glioblastoma
ROCKVILLE, Md., Jan. 8, 2024. Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) ( " Shuttle Pharma " ) today announced they have received the ' Safe to Proceed ' letter from the U.S. Food and Drug Administration (FDA) for the Company ' s investigational... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 8, 2024 Category: Pharmaceuticals Source Type: clinical trials

Clinical Study to Evaluate Cannabidiol Liver Enzyme Elevations and Drug Interactions
Conditions: Cannabidiol; Drug Induced Liver Injury; Drug Interaction Interventions: Drug: Cannabidiol; Drug: Placebo; Drug: Citalopram; Drug: Morphine Sponsors: Food and Drug Administration (FDA); Spaulding Clinical Research LLC Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - January 5, 2024 Category: Research Source Type: clinical trials