The Food and Drug Administration on Thursday granted full approval to Pfizer’s Covid antiviral pill, Paxlovid, for adults who are at high risk of getting severely sick with the virus. Paxlovid is specifically advised for the treatment of mild to moderate Covid in adults older than 50 and people who […]
FDA
FDA Approves First Oral Antiviral Drug for COVID-19
The FDA has granted full approval to nirmatrelvir-ritonavir (Paxlovid) for treating adult outpatients with mild to moderate COVID-19 who are at risk for severe disease, the agency announced on Thursday. “Today’s approval demonstrates that Paxlovid has met the agency’s rigorous standards for safety and effectiveness, and that it remains an […]
FDA Still Struggles to Inspect Foreign Drug Manufacturers After COVID Delays
This story was originally published by ProPublica. For years, U.S. pharmaceutical companies have relied on drugs produced overseas to meet Americans’ medical needs. And for years, it’s been clear that federal drug regulators couldn’t keep up with inspections of the plants that made those drugs. But a series of recent […]
No clear association between Paxlovid and COVID-19 rebound, FDA says
A U.S. Food and Drug Administration analysis did not find a clear association between the COVID-19 antiviral drug Paxlovid and illness rebound, the FDA said in a new report. Rebound rates are around the same in people who took the drug and those who didn’t, the study said. It’s the […]
FDA withdraws emergency use authorization of COVID drug because it is unlikely to be effective against new variants
The U.S. Food and Drug Administration said Thursday it is withdrawing its emergency use authorization of a COVID-19 antibody therapy as a prevention tool because it is unlikely to be effective against variants that are currently circulating. Evusheld, which is made by British-Swedish pharmaceutical and biotechnology company, AstraZeneca, was first […]
FDA OKs emergency use of antibody drug Trump received | Nation
U.S. health officials Saturday agreed to allow emergency use of a second antibody drug to help the immune system fight COVID-19, an experimental medicine that President Donald Trump was given when he was sickened last month. The Food and Drug Administration authorized use of the Regeneron Pharmaceuticals Inc. drug to […]