Coronavirus disease (COVID-19) is an infectious disease caused by the coronavirus SARS-CoV-2. Here we have collected APR news related to the COVID-19 pandemic, vaccination efforts and emerging treatments.
The FDA approved a new indication for Olumiant (baricitinib) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ...
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The FDA has limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically...
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The FDA has expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive ...
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Direct Biologics announced that the FDA has approved the company to proceed with its Phase 3 clinical trial using its investigational EV drug, ExoFlo, to treat Acute Respiratory Distress Syndrome (...
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Novavax, Inc. has initiated administration of the first booster doses of NVX-CoV2373, the company's protein-based COVID-19 vaccine, in the pediatric expansion of the PREVENT-19 pivotal Phase 3 ...
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Novavax, Inc. announced initial results from the Phase 1/2 clinical trial of its COVID-Influenza Combination Vaccine (CIC). The CIC combines Novavax' COVID-19 vaccine, NVX-CoV2373, and its ...
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Wednesday, April 20, 2022
Arcturus Therapeutics Holdings Inc. announced topline data from an ongoing Phase 1/2/3 trial evaluating ARCT-154, Arcturus’ self-amplifying mRNA vaccine candidate against COVID-19 disease caused by ...
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Takeda has received manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Nuvaxovid® Intramuscular Injection (Nuvaxovid), a novel recombinant protein-...
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Health Canada authorized Evusheld (tixagevimab and cilgavimab) for the prevention of COVID-19. After a thorough and independent scientific review of the evidence, the Department has determined that ...
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The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 ...
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Valneva SE announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has granted Conditional Marketing Authorization (CMA) for its inactivated whole-virus ...
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Wednesday, April 13, 2022
Direct Biologics announced that the U.S. Food and Drug Administration (FDA) has awarded their EV drug product ExoFlo with a Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment ...
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Wednesday, April 13, 2022
Novavax, Inc. announced that Swissmedic, the Swiss Agency for Therapeutic Products, has granted Novavax conditional marketing authorization (CMA) for Nuvaxovid™ COVID-19 Vaccine (recombinant, ...
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BioNTech SE (Nasdaq: BNTX) today announced that it is one of the companies in Germany to be granted a pandemic preparedness contract by the Federal Republic of Germany. The framework agreement is ...
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Novavax, Inc. and Serum Institute of India Pvt. announced that the Thailand Food and Drug Administration (Thai FDA) has granted emergency use authorization (EUA) for Novavax' protein-based vaccine for...
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