COVID-19 Coronavirus

The Centers for Disease Control and Prevention (CDC) has officially endorsed COVID-19 booster shots for individuals six months and older as we approach the fall season. Monday, the FDA cleared updated booster shots from Pfizer Inc (NYSE: PFE) and Moderna Inc (NASDAQ:...

Moderna Inc's (NASDAQ: MRNA) clinical trial data from its research assay confirm that its updated COVID-19 vaccine generates an 8.7-fold increase in neutralizing antibodies in humans against BA.2.86 (Pirola), a variant under monitoring.  The updated COVID-19 vaccine is pending...

The European Commission has approved Comirnaty XBB.1.5-adapted COVID-19 vaccine, developed by BioNTech SE (NASDAQ: BNTX)-Pfizer Inc (NYSE: PFE).  It is the third adaptation of this vaccine to respond to new COVID-19 variants. The vaccine is authorized for adults,...

The U.S. Justice Department revealed the results of an extensive crackdown on widespread COVID-19 relief fraud, shedding light on the extent of deceit and manipulation that opportunistic criminals undertook during the global pandemic. As trillions of dollars were disbursed to Americans...

Moderna Inc (NASDAQ: MRNA) announced that preliminary clinical trial data confirm its updated COVID-19 vaccine for the fall 2023 vaccination season showed a significant boost in neutralizing antibodies against EG.5 and FL.1.5.1 variants.  These results suggest that Moderna's...

Virios Therapeutics Inc (NASDAQ: VIRI) announced that female patients diagnosed with Long-COVID illness exhibited clinically and statistically significant improvements related to Long-COVID when treated open-label with a combination of valacyclovir and celecoxib (Val/Cel) for 14 weeks, as...

Invivyd Inc (NASDAQ: IVVD) announced additional initial data from its ongoing Phase 1 healthy volunteer clinical trial of its lead investigational monoclonal antibody (mAb) candidate, VYD222.  VYD222 is a broadly neutralizing, half-life extended mAb candidate in development for the...

Elderly and frail nursing home residents, who could have significantly benefited from antiviral treatments for COVID-19, received inadequate amounts of the medication following their coronavirus infections, even when Pfizer Inc's (NYSE: PFE) Paxlovid pill was readily available....

The European Commission has approved Novavax Inc's (NASDAQ: NVAX) Nuvaxovid (NVX-CoV2373), following a positive opinion for a full authorization from the Committee for Medicinal Products for Human Use of the European Medicines Agency.  The vaccine is now fully authorized as...

Moderna Inc (NASDAQ: MRNA) submitted a regulatory application to the European Medicines Agency (EMA) for its updated COVID-19 vaccine encoding the spike protein for the XBB.1.5 sublineage of SARS-CoV-2. The application is based on guidance from the European Centre for Disease Prevention...

Merck & Co Inc (NYSE: MRK) and Ridgeback Biotherapeutics have reportedly withdrawn their COVID-19 pill application in the European Union (EU). The withdrawal came after the European Medicines Agency cited insufficient data for not backing the drug. Merck had asked the...

As the emergency phase of the COVID-19 pandemic draws to a close, the COVAX initiative, run by Gavi, the WHO, and CEPI, reportedly has $2.6 billion left over that could be used to prepare for other pandemics or to support vaccine manufacturing in Africa. The initiative will conclude at the end of...

Invivyd Inc (NASDAQ: IVVD) announces initial data from its ongoing Phase 1 healthy volunteer clinical trial of VYD222, its investigational monoclonal antibody for COVID-19 prevention. VYD222 is a broadly neutralizing, half-life extended mAb candidate in development to prevent symptomatic...

Thursday, the FDA's Vaccines and Related Biological Products Advisory Committee all 21 members voted "Yes," recommending that updated monovalent COVID shots in the fall and winter targeting the XBB variants, which are now the dominant strains of the SARS-CoV-2 virus in the...

Cue Health Inc (NASDAQ: HLTH) became the first company to receive De Novo authorization from the FDA for its Cue COVID-19 Molecular Test, designed for both home and point-of-care use. The de novo is a device classification process that allows the FDA to classify new devices that are not...