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.

Protocol for TRAUMADORNASE: a prospective, randomized, multicentre, double-blinded, placebo-controlled clinical trial of aerosolized dornase alfa to reduce the incidence of moderate-to-severe hypoxaemia in ventilated trauma patients
DiscussionIf early administration of inhaled dornase alfa actually reduces the incidence of moderate-to-severe hypoxaemia in patients with severe trauma, this new therapeutic strategy may be easily implemented in many clinical trauma care settings. This treatment may facilitate ventilator weaning, reduce the burden of trauma-induced lung inflammation and facilitate recovery and rehabilitation in severe trauma patients.Trial registrationClinicalTrials.gov,NCT03368092. Registered on 11 December 2017. (Source: Trials)
Source: Trials - March 17, 2020 Category: Research Source Type: clinical trials

Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for JNJ-6372 for the Treatment of Non-Small Cell Lung Cancer
RARITAN, NJ, March 10, 2020 – The Janssen Pharmaceutical Companies of Johnson& Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for JNJ-61186372 (JNJ-6372) for the... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - March 10, 2020 Category: Pharmaceuticals Source Type: clinical trials

Novartis Announces MET Inhibitor Capmatinib (INC280), the First Potential Treatment for METex14 Mutated Advanced Non-Small Cell Lung Cancer, Granted Priority FDA Review
EAST HANOVER, N.J., Feb. 11, 2020 /PRNewswire/ -- Novartis announced today that the US Food and Drug Administration (FDA) accepted and granted Priority Review to capmatinib ' s (INC280) New Drug Application (NDA). Capmatinib is a MET... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 11, 2020 Category: Pharmaceuticals Source Type: clinical trials

U.S. FDA Grants Priority Review for Kite ’s KTE-X19 Biologics License Application (BLA) in Relapsed or Refractory Mantle Cell Lymphoma
SANTA MONICA, Calif.--(BUSINESS WIRE)--Feb. 10, 2020-- Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) and granted... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 10, 2020 Category: Pharmaceuticals Source Type: clinical trials

CTI BioPharma Establishes Accelerated Approval Pathway for Pacritinib in Treating Myelofibrosis Patients With Severe Thrombocytopenia
SEATTLE, Feb. 3, 2020 /PRNewswire/ -- CTI BioPharma Corp. (Nasdaq: CTIC) today announced that following a meeting with the U.S. Food and Drug Administration ( " FDA " or " the Agency " ), CTI has reached agreement on an... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 3, 2020 Category: Pharmaceuticals Source Type: clinical trials

Pulmatrix Receives Fast Track Designation for Pulmazole for the Treatment of Asthma-ABPA
LEXINGTON, Mass., Jan. 30, 2020 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PUR1900 ( " Pulmazole " ), the Company ' s... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 30, 2020 Category: Pharmaceuticals Source Type: clinical trials

Durect Corporation Announces Outcome of FDA Advisory Committee Meeting for Posimir
CUPERTINO, Calif., Jan. 17, 2020 /PRNewswire/ -- Durect Corporation (Nasdaq: DRRX) today announced that the U.S. Food and Drug Administration ' s (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) met yesterday to discuss the... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 17, 2020 Category: Pharmaceuticals Source Type: clinical trials

Efficacy and safety of Guhong injection for treating coronary microvascular disease: study protocol for a randomized controlled trial
DiscussionThis trial is strictly designed in accordance with principles and regulations issued by the China Food and Drug Administration (CFDA). The results should provide high-quality evidence on the efficacy and safety ofGuhong injection in the treatment of CMVD.Trial registrationChinese Clinical Trials Registry, ID:ChiCTR1900022902. Registered on 27 April 2019. (Source: Trials)
Source: Trials - January 12, 2020 Category: Research Source Type: clinical trials

FDA Complete Response Letter for Investigational Cabotegravir and Rilpivirine Long-Acting HIV Treatment
TITUSVILLE, N.J., December 21, 2019– The Janssen Pharmaceutical Companies of Johnson& Johnson announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) in response to ViiV Healthcare’s... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 21, 2019 Category: Pharmaceuticals Source Type: clinical trials

Complete Response Letter Issued from U.S. FDA for Investigational Long-Acting HIV Regimen
TITUSVILLE, N.J., December 21, 2019– The Janssen Pharmaceutical Companies of Johnson& Johnson announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) in response to ViiV Healthcare’s... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 21, 2019 Category: Pharmaceuticals Source Type: clinical trials

FDA Advisory Committee Votes Unanimously to Support the Use of Teprotumumab for the Treatment of Thyroid Eye Disease (TED)
DUBLIN--(BUSINESS WIRE)--Dec. 13, 2019-- Horizon Therapeutics plc (Nasdaq: HZNP) today announced that the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) of the U.S. Food and Drug Administration (FDA) voted... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 13, 2019 Category: Pharmaceuticals Source Type: clinical trials

Chi-Med Announces Surufatinib Granted FDA Orphan Drug Designation for Pancreatic Neuroendocrine Tumors
LONDON, Nov. 25, 2019 (GLOBE NEWSWIRE) -- Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) today announces that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug designation to surufatinib... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - November 25, 2019 Category: Pharmaceuticals Source Type: clinical trials

FDA Grants Priority Review to Genentech ’s Risdiplam for Spinal Muscular Atrophy
South San Francisco, CA -- November 24, 2019 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and granted Priority... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - November 24, 2019 Category: Pharmaceuticals Source Type: clinical trials

U.S. FDA Grants Fast Track Designation to Astellas for the Development of ASP1128 for Patients at Risk for Acute Kidney Injury
TOKYO, Oct. 28, 2019 /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 the... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 28, 2019 Category: Pharmaceuticals Source Type: clinical trials

NuCana Announces FDA Clearance to Commence Phase III Study of Acelarin (NUC-1031) for the First-Line Treatment of Patients with Biliary Tract Cancer
EDINBURGH, United Kingdom, Oct. 25, 2019 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA) announced that the US Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) for its Phase III study (NuTide:121) of the... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 25, 2019 Category: Pharmaceuticals Source Type: clinical trials