The U.S. Food and Drug Administration granted Emergency Use Authorization (EUA) for Siemens Healthineers’ CLINITEST Rapid COVID-19 Antigen Self-Test, providing nationwide access to a new at-home or over-the-counter self-test as Covid-19 testing needs continue to grow for individuals, families and businesses.
Roche said on December 24 that the U.S. Food and Drug Administration granted Emergency Use Authorization (EUA) to the company’s COVID-19 at-home rapid test that can be used by people as young as 14.
The U.S. Food and Drug Administration greenlit Merck’s and Ridgeback Biotherapeutics’ molnupiravir under Emergency Use Authorization for the treatment of mild to moderate Covid-19 infections in adults who are at high risk of progression to severe disease.
The United States on December 22 authorized Pfizer Inc.’s antiviral Covid-19 pill for people ages 12 and older at risk of severe illness, the first oral and at-home treatment as well as a new tool against the fast-spreading Omicron variant.
The U.S. Food and Drug Administration authorized the emergency use of Pfizer Inc.’s Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for the treatment of mild-to-moderate Covid-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg [88 lbs]) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
The U.S. Food and Drug Administration on December 8 authorized the use of AstraZeneca’s antibody cocktail to prevent Covid-19 infections in individuals with weak immune systems or a history of severe side effects from coronavirus vaccines.
Moderna Inc. said on November 17 the company had applied with the U.S. Food and Drug Administration for authorization of the Covid-19 booster vaccine for all adults aged 18 and older.
Pfizer plans to seek Emergency Use Authorization (EUA) for an antiviral Covid-19 treatment following an interim analysis of Phase II/III data shown to be statistically and clinically meaningful.
Ocugen Inc. announced Nov. 5 that the biopharmaceutical company submitted a request to the U.S. Food and Drug Administration for Emergency Use Authorization (EUA) of the Covid-19 vaccine candidate BBV152, known as Covaxin outside of the United States, for pediatric use.
Vaccine developer Novavax Inc. said on Nov. 4 that the company completed the submission process for emergency use listing of the Covid-19 vaccine candidate NVX-CoV2373 with the World Health Organization.
