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.

Xentria Announces the Initiation of a Clinical Trial for XTMAB-16 for the Treatment of Sarcoidosis
CHICAGO--(BUSINESS WIRE) June 22, 2021--Xentria Inc., a biopharmaceutical company focused on developing novel biologics to address unmet clinical needs, today announced that the U.S. Food and Drug Administration (“FDA”) has confirmed... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - June 22, 2021 Category: Pharmaceuticals Source Type: clinical trials

Boehringer Ingelheim and Zealand Pharma Receive FDA Fast Track Designation for BI 456906 for NASH
Ingelheim, Germany and Copenhagen, Denmark, 2 June, 2021 – Boehringer Ingelheim and Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078) today announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation to... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - June 2, 2021 Category: Pharmaceuticals Source Type: clinical trials

Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma
June 1, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson& Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for teclistamab in the... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - June 1, 2021 Category: Pharmaceuticals Source Type: clinical trials

Clinical trial reporting performance of thirty UK universities on ClinicalTrials.gov —evaluation of a new tracking tool for the US clinical trial registry
AbstractClinical trial transparency forms the foundation of evidence-based medicine, and trial sponsors, especially publicly funded institutions such as universities, have an ethical and scientific responsibility to make the results of clinical trials publicly available in a timely fashion. We assessed whether the thirty UK universities receiving the most Medical Research Council funding in 2017 –2018 complied with World Health Organization best practices for clinical trial reporting on the US Clinical Trial Registry (ClinicalTrials.gov). Firstly, we developed and evaluated a novel automated tracking tool (clinical-trial...
Source: Trials - June 1, 2021 Category: Research Source Type: clinical trials

Boehringer Ingelheim ’s BI 425809 for Cognitive Impairment Associated with Schizophrenia Receives FDA Breakthrough Therapy Designation
RIDGEFIELD, CT, May 24, 2021– Boehringer Ingelheim today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for BI 425809 for the treatment of Cognitive Impairment Associated with... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - May 24, 2021 Category: Pharmaceuticals Source Type: clinical trials

FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic
May 10, 2021 -- Today, the U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - May 10, 2021 Category: Pharmaceuticals Source Type: clinical trials

Efficacy and safety of Naoxintong capsule for treating chronic stable angina: study protocol for a randomized controlled trial
DiscussionWe designed this study in accordance with principles and regulations issued by the China Food and Drug Administration (CFDA). The results will provide clinical evidence of the efficacy and safety of NXT Capsule in the treatment of CSA.Trial registrationChinese Clinical Trial RegistryChiCTR2100044563. Registered on 24 March 2020. (Source: Trials)
Source: Trials - May 10, 2021 Category: Research Source Type: clinical trials

Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine
NEW YORK& MAINZ, Germany--(BUSINESS WIRE) May 07, 2021 -- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the initiation of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - May 7, 2021 Category: Pharmaceuticals Source Type: clinical trials

ChemoCentryx Announces Results of FDA Advisory Committee Meeting on Avacopan in ANCA-Associated Vasculitis
SAN CARLOS, Calif., May 06, 2021 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq: CCXI), today announced the outcome of the U.S. Food and Drug Administration (“FDA”) Arthritis Advisory... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - May 6, 2021 Category: Pharmaceuticals Source Type: clinical trials

Amgen's Investigational Targeted Treatment Bemarituzumab Granted Breakthrough Therapy Designation
THOUSAND OAKS, Calif., April 19, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for investigational bemarituzumab as... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 19, 2021 Category: Pharmaceuticals Source Type: clinical trials

FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab
April 16, 2021 -- Today, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 16, 2021 Category: Pharmaceuticals Source Type: clinical trials

Lilly Requests Revocation of Emergency Use Authorization for Bamlanivimab Alone to Complete Transition to Bamlanivimab and Etesevimab Together for Treatment of COVID-19 in the U.S.
INDIANAPOLIS, April 16, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) has requested the U.S. Food and Drug Administration (FDA) revoke the Emergency Use Authorization (EUA) for bamlanivimab (LY-CoV555) 700 mg alone. Lilly made... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 16, 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

GSK and Vir Biotechnology Announce Submission of Emergency Use Authorization Request to FDA for VIR-7831 for the Early Treatment of COVID-19
London, UK and San Francisco, US -- 26 March 2021 GlaxoSmithKline plc and Vir Biotechnology, Inc. today announced the submission of an application to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - March 26, 2021 Category: Pharmaceuticals Source Type: clinical trials

Joint FDA Advisory Committee Votes on Application for Tanezumab for the Treatment of Osteoarthritis Pain
NEW YORK& INDIANAPOLIS--(BUSINESS WIRE) March 25, 2021 -- Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced the outcome of the U.S. Food and Drug Administration (FDA) Joint Arthritis Advisory Committee and Drug Safety... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - March 25, 2021 Category: Pharmaceuticals Source Type: clinical trials