May 5, 2021 | News, Regulatory
Pfizer & BioNTech’s COVID-19 vaccine is expected to receive FDA approval for adolescents ages 12 and older sometime this week. The expected approval comes from a Phase III trial in adolescents between the ages of 12 and 15 with 2,260 participants that...
Apr 26, 2021 | News, Regulatory
The U.S. Food and Drug Administration (FDA) and the Center for Disease Control (CDC) lifted restrictions on the single-shot Johnson & Johnson vaccination for COVID-19 this past Friday (April 23) after the FDA’s Advisory Committee on Immunization Practices...
Apr 22, 2021 | News, Regulatory
India recorded today the highest number of COVID-19 cases in a day today (4/22) at 314,835 infections, surpassing the previous record from the United States at 297,430. The exponential rise in cases have caused fear regarding hospital oxygen supply levels to treat...
Apr 16, 2021 | News, Regulatory
The U.S. Food and Drug Administration’s (FDA) Advisory Committee on Immunization Practices (ACIP) met on April 14 to provide its recommendation regarding the pause of the Johnson & Johnson COVID-19 vaccine due to the association of extremely rare but...
Mar 25, 2021 | News, Regulatory
The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) LetsGetChecked’s COVID-19 at-home test to sell directly to consumers at retail stores as well as online. Peter Foley, CEO and Founder of LetsGetChecked stated, “While the...
