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...
Mar 5, 2021 | News, Regulatory
The U.S. Food and Drug Administration (FDA) provided guidance that addresses changes to the supply chain due to COVID-19, including its regulatory process for manufacturing and controls (CMS) and chemistry. Materials like glass vials, stoppers, test swabs, and...
Dec 30, 2020 | News, Regulatory
NeuroRx and Relief Therapeutics have completed enrollment for their phase 2b/3 clinical trial for their treatment of respiratory failure in patients with severe cases of COVID-19. The trial, who’s top-line data is expected in one month, has...
Dec 21, 2020 | News, Regulatory
On Friday (12/18) The U.S Food and Drug Administration granted Moderna Emergency Use Authorization for their COVID-19 vaccine in adults over 18 years old. In addition to Pfizer’s vaccine, the U.S government agreed to purchase 200 million doses from Moderna which will...
Nov 23, 2020 | News, Regulatory
After an expert panel review of Gilead’s Remdesivir, no evidence was found that it was effective in treating COVID-19. In October, the U.S. Food and Drug Administration (FDA) granted the drug approval for usage in hospitals, and after rescinding the...
