Clinical Trial News Archive - November 2021
November 1, 2021
- Janssen Announces Extension of U.S. FDA BLA PDUFA Date for BCMA CAR-T Ciltacabtagene Autoleucel
- Novavax Files for COVID-19 Vaccine Authorization with Health Canada and Completes Submission for Rolling Review to European Medicines Agency
- Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in Indonesia
November 2, 2021
- Merus Announces Regulatory Update on Zenocutuzumab, Financial Results for the Third Quarter and Provides Business Update
- Ionis Initiates Pivotal Phase 3 Clinical Study of Olezarsen in Patients with Severe Hypertriglyceridemia
November 3, 2021
November 4, 2021
- US Food and Drug Administration Declines Emergency Use Authorization for Zyesami (aviptadil) for Patients with Critical COVID-19 with Respiratory Failure
- Amylyx Pharmaceuticals Announces Participants Dosed in the Global Phase 3 PHOENIX Study of AMX0035 in ALS
- Novartis Iptacopan Meets Primary Endpoints in Phase II Study in Rare Kidney Disease C3 Glomerulopathy (C3G)
- Novavax Files COVID-19 Vaccine for Emergency Use Listing with World Health Organization
- Merck and Ridgeback’s Molnupiravir, an Oral COVID-19 Antiviral Medicine, Receives Authorization in the U.K.
November 5, 2021
- GSK Announces Positive Phase III Efficacy and Safety Data for Daprodustat in Patients with Anemia Due to Chronic Kidney Disease
- Pfizer’s Covid-19 Oral Antiviral Treatment Paxlovid Reduces Risk of Hospitalization and Death
November 8, 2021
November 9, 2021
- Moderna Files to Expand the Conditional Marketing Authorization for its COVID-19 Vaccine in the European Union to Include Children Ages 6-11 Years
- Merck and Ridgeback Announce U.S. Government to Purchase 1.4 Million Additional Courses of Molnupiravir, an Investigational Oral Antiviral Medicine, for the Treatment of Mild-to-Moderate COVID-19 in At Risk Adults
- Amylyx Pharmaceuticals Announces Results from PEGASUS Trial of AMX0035 in Alzheimer’s Disease at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference
November 11, 2021
November 12, 2021
November 15, 2021
November 16, 2021
November 17, 2021
November 18, 2021
- Reata Pharmaceuticals Receives Fast Track Designation From the FDA for Omaveloxolone for the Treatment of Friedreich’s Ataxia
- The Lancet Neurology Publishes Pivotal Phase 3 PROPEL Study Results of AT-GAA in Late-Onset Pompe Disease
- Quizartinib Added to Chemotherapy Demonstrates Superior Overall Survival Compared to Chemotherapy Alone in Adult Patients with Newly Diagnosed FLT3-ITD Positive AML
- TROPION-Breast01 Phase 3 Trial of Datopotamab Deruxtecan Initiated in Patients with Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer
- New Analyses of Two AZD7442 COVID-19 Phase III Trials in High-Risk Populations Confirm Robust Efficacy and Long-Term Prevention
- Ionis Initiates Phase 3 Clinical Program of Donidalorsen in Patients with Hereditary Angioedema
November 19, 2021
- Moderna Announces FDA Authorization of Booster Dose of COVID-19 Vaccine in the U.S. for Adults 18 Years and Older
- Pfizer and BioNTech Receive Expanded U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster to Include Individuals 18 and Older
November 21, 2021
November 22, 2021
November 26, 2021
- Merck and Ridgeback Biotherapeutics Provide Update on Results from MOVe-OUT Study of Molnupiravir, an Investigational Oral Antiviral Medicine, in At Risk Adults With Mild-to-Moderate COVID-19
- Moderna Announces Strategy to Address Omicron (B.1.1.529) SARS-CoV-2 Variant
November 29, 2021
- Bristol Myers Squibb’s Applications for Deucravacitinib for the Treatment of Moderate to Severe Plaque Psoriasis Accepted by U.S. Food and Drug Administration and Validated by European Medicines Agency
- Johnson & Johnson to Evaluate Its COVID-19 Vaccine Against New Omicron COVID-19 Variant
November 30, 2021
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