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.

Efficacy and safety of nitazoxanide plus atazanavir/ritonavir for the treatment of moderate to severe COVID-19 (NACOVID): A structured summary of a study protocol for a randomised controlled trial
AbstractObjectivesTo investigate the efficacy and safety of repurposed antiprotozoal and antiretroviral drugs, nitazoxanide and atazanavir/ritonavir, in shortening the time to clinical improvement and achievement of SARS-CoV-2 polymerase chain reaction (PCR) negativity in patients diagnosed with moderate to severe COVID-19.Trial designThis is a pilot phase 2, multicentre 2-arm (1:1 ratio) open-label randomised controlled trial.ParticipantsPatients with confirmed COVID-19 diagnosis (defined as SARS-CoV-2 PCR positive nasopharyngeal swab) will be recruited from four participating isolation and treatment centres in Nigeria: t...
Source: Trials - January 4, 2021 Category: Research Source Type: clinical trials

Janssen Initiates Rolling Submission of a Biologics License Application to U.S. FDA for BCMA CAR-T Therapy Ciltacabtagene Autoleucel (cilta-cel) for the Treatment of Relapsed and/or Refractory Multiple Myeloma
December 21, 2020 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson& Johnson announced today the initiation of a rolling submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 21, 2020 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

Moderna Announces FDA Authorization of Moderna COVID-19 Vaccine in U.S.
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec. 18, 2020-- Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the U.S. Food and Drug Administration’s... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 18, 2020 Category: Pharmaceuticals Source Type: clinical trials

U.S. FDA Accepts for Priority Review the Biologics License Application for Pfizer ’s Investigational 20-valent Pneumococcal Conjugate Vaccine for Adults 18 Years of Age and Older
NEW YORK--(BUSINESS WIRE)-- December 08, 2020 Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for priority review a Biologics License Application (BLA) for its 20-valent pneumococcal conjugate vaccine... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 8, 2020 Category: Pharmaceuticals Source Type: clinical trials

Amgen's Sotorasib Granted Breakthrough Therapy Designation For Advanced Or Metastatic Non-Small Cell Lung Cancer Patients With KRAS G12C Mutation
THOUSAND OAKS, Calif., Dec. 8, 2020 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for its investigational... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - December 8, 2020 Category: Pharmaceuticals Source Type: clinical trials

FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate
November 20, 2020 -- The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10 to discuss the request for emergency use authorization (EUA) of a COVID-19... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - November 20, 2020 Category: Pharmaceuticals Source Type: clinical trials

Baricitinib and Remdesivir Combination Receives Emergency Use Authorization from the FDA for the Treatment of Hospitalized Patients with COVID-19
INDIANAPOLIS, Nov. 19, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - November 19, 2020 Category: Pharmaceuticals Source Type: clinical trials

Samsung Bioepis and Biogen Announce FDA Filing Acceptance of SB11, A Proposed Biosimilar Referencing Lucentis ® (ranibizumab)
INCHEON, South Korea and CAMBRIDGE, Mass., Nov. 18, 2020 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - November 18, 2020 Category: Pharmaceuticals Source Type: clinical trials

Rilzabrutinib Granted FDA Fast Track Designation for Treatment of Immune Thrombocytopenia
PARIS– November 18, 2020 – The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to the oral investigational Bruton’s tyrosine kinase (BTK) inhibitor, rilzabrutinib, which has the potential to... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - November 18, 2020 Category: Pharmaceuticals Source Type: clinical trials

FDA Grants Priority Review for Avalglucosidase Alfa, a Potential New Therapy for Pompe Disease
PARIS– November 18, 2020 - The U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for avalglucosidase alfa for long-term enzyme replacement therapy for the treatment of patients... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - November 18, 2020 Category: Pharmaceuticals Source Type: clinical trials

ViiV Healthcare Receives FDA Breakthrough Therapy Designation for Investigational, Long-Acting Cabotegravir for HIV prevention
17 November 2020 -- ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA)... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - November 17, 2020 Category: Pharmaceuticals Source Type: clinical trials

Bristol Myers Squibb Provides Regulatory Update on Lisocabtagene Maraleucel (liso-cel)
PRINCETON, N.J.--(BUSINESS WIRE) November 16, 2020 -- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has informed the company that its review of the Biologics License Application (BLA) for... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - November 16, 2020 Category: Pharmaceuticals Source Type: clinical trials

Lilly's Neutralizing Antibody Bamlanivimab (LY-CoV555) Receives FDA Emergency Use Authorization for the Treatment of Recently Diagnosed COVID-19
INDIANAPOLIS, Nov. 9, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today granted Emergency Use Authorization (EUA) for Eli Lilly and Company ' s (NYSE: LLY) investigational neutralizing antibody bamlanivimab... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - November 9, 2020 Category: Pharmaceuticals Source Type: clinical trials

Update on FDA Advisory Committee ’s Meeting on Aducanumab in Alzheimer’s Disease
CAMBRIDGE, Mass. and TOKYO, Nov. 06, 2020 (GLOBE NEWSWIRE) -- Today, the U.S. Food and Drug Administration (FDA) Peripheral and Central Nervous System Drugs Advisory Committee voted 1 yes, 8 no and 2 uncertain on the question,“Does Study 302... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - November 6, 2020 Category: Pharmaceuticals Source Type: clinical trials