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.

INOVIO Receives Orphan Drug Designation From U.S. FDA for DNA Medicine INO-3107 To Treat Rare Disease Recurrent Respiratory Papillomatosis (RRP)
PLYMOUTH MEETING, Pa., July 29, 2020 /PRNewswire/ -- INOVIO (NASDAQ: INO) today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation for INO-3107, its DNA medicine being evaluated in a Phase 1/2 trial for... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - July 29, 2020 Category: Pharmaceuticals Source Type: clinical trials

MyoKardia Announces Receipt of Breakthrough Therapy Designation from FDA for Mavacamten for the Treatment of Symptomatic, Obstructive Hypertrophic Cardiomyopathy
BRISBANE, Calif., July 23, 2020 (GLOBE NEWSWIRE) -- MyoKardia, Inc. (Nasdaq: MYOK) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to mavacamten, a novel,... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - July 23, 2020 Category: Pharmaceuticals Source Type: clinical trials

FDA Grants Fast Track Designation For DB102 in Patients with Newly-Diagnosed Glioblastoma (GBM)
SAN DIEGO, July 17, 2020 -- Denovo Biopharma LLC, a pioneer in applying precision medicine to development of innovative therapies, 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 - July 17, 2020 Category: Pharmaceuticals Source Type: clinical trials

Rhythm Pharmaceuticals Receives Rare Pediatric Disease Designation from U.S. Food and Drug Administration for Setmelanotide for Treatment of POMC and LEPR Deficiency Obesities
BOSTON, July 01, 2020 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq:RYTM), a late-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - July 1, 2020 Category: Pharmaceuticals Source Type: clinical trials

GSK Announces FDA Advisory Committee Meeting to Review Belantamab Mafodotin for the Treatment of Patients with Relapsed/Refractory Multiple Myeloma
London UK - 19 June 2020 -- GlaxoSmithKline plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to review data supporting the company’s... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - June 19, 2020 Category: Pharmaceuticals Source Type: clinical trials

Chi-Med Announces Fruquintinib Granted U.S. FDA Fast Track Designation for Metastatic Colorectal Cancer
London: Thursday, June 18, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announces 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 - June 18, 2020 Category: Pharmaceuticals Source Type: clinical trials

A pilot study of therapeutic plasma exchange for serious SARS CoV-2 disease (COVID-19): A structured summary of a randomized controlled trial study protocol
AbstractObjectivesTo evaluate the safety of therapeutic plasma exchange (TPE) in adult patients with serious/life-threatening COVID-19 requiring intensive care unit (ICU) admission, and associated 28-day mortality. Serious and life threatening COVID-19 are defined as per published literature (please, refer to the full protocol, Additional file1). The rationale is that TPE can remove interleukins-3, 6, 8, 10, interferon-gamma and tumor necrosis factor-alpha. Thus, it may reduce the cytokine release syndrome associated with fulminant COVID-19 disease.Trial designPilot, interventional, open-label, randomized controlled multic...
Source: Trials - June 7, 2020 Category: Research Source Type: clinical trials

Gilead ’s Investigational Antiviral Remdesivir Receives U.S. Food and Drug Administration Emergency Use Authorization for the Treatment of COVID-19
FOSTER CITY, Calif.--(BUSINESS WIRE)--May 1, 2020-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the investigational... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - May 1, 2020 Category: Pharmaceuticals Source Type: clinical trials

Alnylam Receives Fast Track Designation for Vutrisiran for the Treatment of the Polyneuropathy of hATTR Amyloidosis
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Apr. 14, 2020-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 14, 2020 Category: Pharmaceuticals Source Type: clinical trials

Genentech Provides Regulatory Update on Risdiplam for the Treatment of Spinal Muscular Atrophy (SMA)
South San Francisco, CA -- April 7, 2020 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 7, 2020 Category: Pharmaceuticals Source Type: clinical trials

INOVIO Initiates Phase 1 Clinical Trial Of Its COVID-19 Vaccine
PLYMOUTH MEETING, Pa., April 6, 2020 /PRNewswire/ -- INOVIO Pharmaceuticals, Inc. (NASDAQ:INO) today announced that the U.S. Food and Drug Administration has accepted the company ' s Investigational New Drug (IND) application for INO-4800, its... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 6, 2020 Category: Pharmaceuticals Source Type: clinical trials

Effect of xenon and dexmedetomidine as adjuncts for general anesthesia on postoperative emergence delirium after elective cardiac catheterization in children: study protocol for a randomized, controlled, pilot trial
DiscussionSevoflurane is the most frequently used anesthetic in young children, but has been indicated as an independent risk factor in the development of emergence delirium. Xenon and dexmedetomidine have both been associated with a reduction in the incidence of emergence delirium. Combining xenon and dexmedetomidine has never been described as a balanced-anesthesia technique in children. Our pilot study will therefore deliver important data required for future prospective clinical trials.Trial registrationEudraCT, 2018 –002258-56. Registered on 20 August 2018.https://www.clinicaltrialsregister.eu. (Source: Trials)
Source: Trials - April 2, 2020 Category: Research Source Type: clinical trials

Rhythm Pharmaceuticals Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Setmelanotide in POMC and LEPR Deficiency Obesities
BOSTON, March 30, 2020 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a late-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - March 30, 2020 Category: Pharmaceuticals Source Type: clinical trials

Gilead Sciences Statement on Request to Rescind Remdesivir Orphan Drug Designation
March 25, 2020 -- Gilead has submitted a request to the U.S. Food and Drug Administration to rescind the orphan drug designation it was granted for the investigational antiviral remdesivir for the treatment of COVID-19 and is waiving all benefits... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - March 25, 2020 Category: Pharmaceuticals Source Type: clinical trials

U.S. Food and Drug Administration (FDA) Grants Emergency IND for Two Coronavirus Patients Treated in New York with CytoDyn ’s Leronlimab
VANCOUVER, Washington, March 19, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the“Company " ), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - March 19, 2020 Category: Pharmaceuticals Source Type: clinical trials