New Drug Applications 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.

Pfizer Reports Additional Data on Paxlovid Supporting Upcoming New Drug Application Submission to U.S. FDA
In the EPIC-SR study of Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir tablets), the novel primary endpoint of self-reported, sustained alleviation of all symptoms for four consecutive days was not met, as previously reported Data... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - June 14, 2022 Category: Pharmaceuticals Source Type: clinical trials

Aldeyra Therapeutics Achieves Primary Endpoint in Phase 3 TRANQUILITY ‑2 Trial in Dry Eye Disease and Intends to Submit New Drug Application for Symptoms and Three Sign Endpoints of Dry Eye Disease
LEXINGTON, Mass.--(BUSINESS WIRE)--Jun. 8, 2022-- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the achievement of the primary endpoint in the Phase 3 TRANQUILITY-2 clinical trial (TRANQUILITY-2) of reproxalap, an... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - June 8, 2022 Category: Pharmaceuticals Source Type: clinical trials

FDA Lifts Clinical Hold on Investigational Lenacapavir for the Treatment and Prevention of HIV
FOSTER CITY, Calif.--(BUSINESS WIRE)--May 16, 2022-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) has lifted the clinical hold placed on the company’s Investigational New Drug Application... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - May 16, 2022 Category: Pharmaceuticals Source Type: clinical trials

AbbVie Seeks New Indication for IMBRUVICA (ibrutinib) in Pediatric Patients with Chronic Graft Versus Host Disease (cGVHD)
NORTH CHICAGO, Ill., Feb. 28, 2022. AbbVie today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for IMBRUVICA (ibrutinib) for the treatment of pediatric and adolescent... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 28, 2022 Category: Pharmaceuticals Source Type: clinical trials

AbbVie Submits Supplemental New Drug Application to U.S. FDA for cariprazine (VRAYLAR) for the Adjunctive Treatment of Major Depressive Disorder
NORTH CHICAGO, Ill., Feb. 22, 2022. AbbVie today announced that it has submitted a supplemental New Drug Application (sNDA) for cariprazine (VRAYLAR) to the U.S. Food and Drug Administration (FDA) for the adjunctive treatment of major depressive... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 22, 2022 Category: Pharmaceuticals Source Type: clinical trials

Eagle Pharmaceuticals on Track to Support Submission of New Drug Application in Second Quarter 2022 for Landiolol, a Beta-1 Adrenergic Blocker
WOODCLIFF LAKE, N.J.--(BUSINESS WIRE) January 31, 2022 -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the“Company”) today announced that AOP Orphan Pharmaceuticals GmbH, Member of the AOP Health Group,... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 31, 2022 Category: Pharmaceuticals Source Type: clinical trials

Levo Therapeutics Receives Complete Response Letter From FDA for Its New Drug Application for LV-101 (Intranasal Carbetocin) for the Treatment of Prader-Willi Syndrome
CHICAGO, Jan. 18, 2022 (GLOBE NEWSWIRE) -- Levo Therapeutics, Inc., a biotechnology company dedicated to using genetic insights to advance treatments for Prader-Willi syndrome (PWS) and related disorders, announced today that it has received a... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 18, 2022 Category: Pharmaceuticals Source Type: clinical trials

Teva and MedinCell Announce FDA Acceptance of New Drug Application for TV-46000/mdc-IRM as a Treatment for Patients with Schizophrenia
PARSIPPANY, N.J., TEL AVIV& PARIS--(BUSINESS WIRE) August 31, 2021 -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and MedinCell (Euronext: MEDCL)announced today that the New Drug... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - August 31, 2021 Category: Pharmaceuticals Source Type: clinical trials

Phathom Pharmaceuticals Announces Positive Topline Results from Pivotal Phase 3 Trial of Vonoprazan in Helicobacter pylori (H. pylori) Infection; Study Met All Primary and Secondary Endpoints
Both vonoprazan-based treatment regimens demonstrated superior eradication rates vs. a standard of care proton pump inhibitor (PPI)-based triple therapy New Drug Application (NDA) submissions targeted for Q4 2021 FLORHAM PARK, N.J., April 29,... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 29, 2021 Category: Pharmaceuticals Source Type: clinical trials

FibroGen Announces FDA Advisory Committee to Review Roxadustat New Drug Application Tentatively Scheduled for July 15, 2021
SAN FRANCISCO, April 06, 2021 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) announced that the U.S. Food and Drug Administration (FDA) has informed the Company late today it has tentatively scheduled... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 6, 2021 Category: Pharmaceuticals Source Type: clinical trials

On Target Laboratories Announces U.S. FDA Acceptance and Priority Review of New Drug Application for Pafolacianine Sodium Injection for Identification of Ovarian Cancer During Surgery
WEST LAFAYETTE, Ind., March 3, 2021 /PRNewswire/ -- On Target Laboratories, Inc., a privately-held biotechnology company developing fluorescent markers to target and illuminate cancer during surgery, today announced that the U.S. Food and... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - March 3, 2021 Category: Pharmaceuticals Source Type: clinical trials

Marinus Pharmaceuticals Receives Positive Response from FDA on Sufficiency of One Phase 3 Clinical Trial for Filing of New Drug Application (NDA) for the Use of Ganaxolone in CDKL5 Deficiency Disorder (CDD)
RADNOR, Pa.--(BUSINESS WIRE) January 13, 2021-- Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders, today announced it has received a... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - January 13, 2021 Category: Pharmaceuticals Source Type: clinical trials

Update on US Regulatory Review of Roxadustat in Anemia of Chronic Kidney Disease
18 December 2020 -- The US Food and Drug Administration (FDA) has requested further clarifying analyses of clinical data, to complete its review of the New Drug Application (NDA) for roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 18, 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

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