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

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

Telix Pharmaceuticals Submits New Drug Application to US FDA for Prostate Cancer Imaging Product
MELBOURNE, Australia and INDIANAPOLIS, Sept. 24, 2020 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX,‘Telix’, the‘Company’) today announces it has submitted a New Drug Application (NDA) to the United States... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - September 24, 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

Myovant Sciences Announces FDA Acceptance of New Drug Application for Once-Daily Relugolix Combination Tablet for Uterine Fibroids
BASEL, Switzerland, Aug. 17, 2020 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced that its New Drug Application (NDA) for once-daily, oral... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - August 17, 2020 Category: Pharmaceuticals Source Type: clinical trials

Aldeyra Therapeutics Announces New Drug Application (NDA) Development Plans for Dry Eye Disease
LEXINGTON, Mass.--(BUSINESS WIRE)--Jul. 7, 2020-- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - July 21, 2020 Category: Pharmaceuticals Source Type: clinical trials

Apellis Announces Plans to Submit NDA for Pegcetacoplan in Paroxysmal Nocturnal Hemoglobinuria (PNH)
WALTHAM, Mass., May 21, 2020 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company pioneering targeted C3 therapies, today announced plans to submit a New Drug Application (NDA) for... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - May 21, 2020 Category: Pharmaceuticals Source Type: clinical trials

Sunovion Discontinues Dasotraline Program
May 13, 2020 -- MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Sunovion Pharmaceuticals Inc. (Sunovion) today announced that it has withdrawn the New Drug Applications (NDAs) for dasotraline, a novel dopamine and norepinephrine reuptake inhibitor... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - May 13, 2020 Category: Pharmaceuticals Source Type: clinical trials

Mayne Pharma Submits NDA for E4/DRSP to the FDA
16 April 2020, Adelaide Australia and Liege, Belgium: Mayne Pharma Group Limited (ASX: MYX) and Mithra Pharmaceuticals, SA (Euronext Brussels: MITRA) today announced that Mayne Pharma has submitted a New Drug Application (NDA) to the US Food and... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 16, 2020 Category: Pharmaceuticals 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

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

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

Zosano Pharma Announces Completion of Pre-NDA Meetings with FDA for Qtrypta ™
FREMONT, Calif., Nov. 13, 2019 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced that it has received minutes from pre- New Drug Application... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - November 13, 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

AstraZeneca Announces FDA Complete Response Letter Regarding NDA for PT010 in COPD
October 1, 2019 -- AstraZeneca today announced that the US Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for PT010 (budesonide/glycopyrronium/formoterol fumarate), an inhaled... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 1, 2019 Category: Pharmaceuticals Source Type: clinical trials